Trial Outcomes & Findings for A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology (NCT NCT04868617)
NCT ID: NCT04868617
Last Updated: 2025-04-30
Results Overview
The peristomal skin condition measured by the Decision Tree Score on baseplate level at steady state (scale from 0-3). Higher score means worse outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
after 5 weeks
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Test Product - the Non-CE Marked Product, Then Standard of Care
Participants first received the test product (the non-Conformité Européene marked product) for 35 -1/+3 days. Then there was a cross-over and the participants received the standard of care (the Conformité Européene marked product) for 35 -1/+3 days. There was no 'Washout period'
The test product used was the non-Conformité Européene marked product which was a stoma product based on the flat SenSura® Mio 1-piece and the flat 2-piece with mechanical coupling product that includes a novel skin protective layer in the baseplate.
The following standard of care products (the Conformité Européene marked product) was used in this investigation:
* SenSura® Mio 1-piece flat, Midi bag with normal outlet and
* SenSura® Mio 2-piece with mechanical coupling flat, Maxi or Midi bag with normal outlet
|
Standard of Care, Then the Test Product - the Non-CE Marked Product
Participants first received standard of care (the Conformité Européene marked product) for 35 -1/+3 days. Then there was a cross-over and the participants received the test product (the non-Conformité Européene marked comparator product) for 35 -1/+3 days. There was no 'Washout period'.
The test product used was the non-Conformité Européene marked product which was a stoma product based on the flat SenSura® Mio 1-piece and the flat 2-piece with mechanical coupling product that includes a novel skin protective layer in the baseplate.
The following standard of care products (the Conformité Européene marked product) was used in this investigation:
* SenSura® Mio 1-piece flat, Midi bag with normal outlet and
* SenSura® Mio 2-piece with mechanical coupling flat, Maxi or Midi bag with normal outlet
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
|
Overall Study
COMPLETED
|
38
|
41
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Test Product - the Non-CE Marked Product, Then Standard of Care
Participants first received the test product (the non-Conformité Européene marked product) for 35 -1/+3 days. Then there was a cross-over and the participants received the standard of care (the Conformité Européene marked product) for 35 -1/+3 days. There was no 'Washout period'
The test product used was the non-Conformité Européene marked product which was a stoma product based on the flat SenSura® Mio 1-piece and the flat 2-piece with mechanical coupling product that includes a novel skin protective layer in the baseplate.
The following standard of care products (the Conformité Européene marked product) was used in this investigation:
* SenSura® Mio 1-piece flat, Midi bag with normal outlet and
* SenSura® Mio 2-piece with mechanical coupling flat, Maxi or Midi bag with normal outlet
|
Standard of Care, Then the Test Product - the Non-CE Marked Product
Participants first received standard of care (the Conformité Européene marked product) for 35 -1/+3 days. Then there was a cross-over and the participants received the test product (the non-Conformité Européene marked comparator product) for 35 -1/+3 days. There was no 'Washout period'.
The test product used was the non-Conformité Européene marked product which was a stoma product based on the flat SenSura® Mio 1-piece and the flat 2-piece with mechanical coupling product that includes a novel skin protective layer in the baseplate.
The following standard of care products (the Conformité Européene marked product) was used in this investigation:
* SenSura® Mio 1-piece flat, Midi bag with normal outlet and
* SenSura® Mio 2-piece with mechanical coupling flat, Maxi or Midi bag with normal outlet
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Device deficiency
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total ITT Population Baseline Measures
n=79 Participants
The non-CE marked test product is a stoma product based on the flat SenSura® Mio 1-piece (1-pc) and the flat 2-piece with mechanical coupling (2-pc MC) product that includes a novel skin protective layer in the baseplate.
Arm 1: Participants first received the non-Conformité Européene marked test product for 35 -1/+3 days. Then there was a cross-over and the participants received the Conformité Européene comparator product (standard of care) for 35 -1/+3 days.
Arm 2: Participants first received the Conformité Européene marked comparator product for 35 -1/+3 days. Then there was a cross-over and the participants received the non-Conformité Européene test product for 35 -1/+3 days.
|
|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 13.2 • n=79 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=79 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=79 Participants
|
|
Region of Enrollment
Denmark
|
5 participants
n=79 Participants
|
|
Region of Enrollment
Sweden
|
11 participants
n=79 Participants
|
|
Region of Enrollment
Norway
|
13 participants
n=79 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=79 Participants
|
|
Region of Enrollment
United Kingdom
|
28 participants
n=79 Participants
|
|
BMI (kg/m^2)
|
28.2 kg/m^2
STANDARD_DEVIATION 6.5 • n=79 Participants
|
|
Height (cm)
|
172.2 cm
STANDARD_DEVIATION 10.1 • n=79 Participants
|
|
Weight (kg)
|
83.8 kg
STANDARD_DEVIATION 20.1 • n=79 Participants
|
|
Stoma age (Years since surgery)
|
11.2 years
STANDARD_DEVIATION 10.4 • n=79 Participants
|
|
Type of stoma; ileostomy / colostomy
Ileostomy
|
53 Participants
n=79 Participants
|
|
Type of stoma; ileostomy / colostomy
Colostomy
|
26 Participants
n=79 Participants
|
|
Stoma diameter (mm)
|
29.2 mm
STANDARD_DEVIATION 5.6 • n=79 Participants
|
PRIMARY outcome
Timeframe: after 5 weeksPopulation: Intention to treat (ITT)
The peristomal skin condition measured by the Decision Tree Score on baseplate level at steady state (scale from 0-3). Higher score means worse outcome
Outcome measures
| Measure |
Test Product
n=79 Participants
The non-Conformité Européene marked test product is a stoma product based on the flat SenSura® Mio 1-piece and the flat 2-piece with mechanical coupling product that includes a novel skin protective layer in the baseplate.
Arm 1: Participants first received the non-Conformité Européene marked test product for 35 -1/+3 days. Then there was a cross-over and the participants received the Conformité Européene comparator product (standard of care) for 35 -1/+3 days.
Arm 2: Participants first received the Conformité Européene marked comparator product for 35 -1/+3 days. Then there was a cross-over and the participants received the non-Conformité Européene test product for 35 -1/+3 days.
|
Standard of Care
n=79 Participants
The following comparator products (standard of care) will be used in this investigation:
* SenSura® Mio 1-piece flat, Midi bag with normal outlet and
* SenSura® Mio 2-piece with mechanical coupling flat, Maxi or Midi bag with normal outlet
Arm 1: Participants first received the non-Conformité Européene marked test product for 35 -1/+3 days. Then there was a cross-over and the participants received the Conformité Européene comparator product (standard of care) for 35 -1/+3 days.
Arm 2: Participants first received the Conformité Européene marked comparator product for 35 -1/+3 days. Then there was a cross-over and the participants received the non-Conformité Européene test product for 35 -1/+3 days.
|
|---|---|---|
|
The Peristomal Skin Condition Measured by the Decision Tree Score (Scale From 0-3)
|
1.8 score on a scale
Interval 1.6 to 2.0
|
2.0 score on a scale
Interval 1.8 to 2.2
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: Intention to treat (ITT)
A health-related quality of life measured by the DLQI score evaluated at the end of each test period (scale from 0-30, the higher the score, the worse the QoL for the participant)
Outcome measures
| Measure |
Test Product
n=79 Participants
The non-Conformité Européene marked test product is a stoma product based on the flat SenSura® Mio 1-piece and the flat 2-piece with mechanical coupling product that includes a novel skin protective layer in the baseplate.
Arm 1: Participants first received the non-Conformité Européene marked test product for 35 -1/+3 days. Then there was a cross-over and the participants received the Conformité Européene comparator product (standard of care) for 35 -1/+3 days.
Arm 2: Participants first received the Conformité Européene marked comparator product for 35 -1/+3 days. Then there was a cross-over and the participants received the non-Conformité Européene test product for 35 -1/+3 days.
|
Standard of Care
n=79 Participants
The following comparator products (standard of care) will be used in this investigation:
* SenSura® Mio 1-piece flat, Midi bag with normal outlet and
* SenSura® Mio 2-piece with mechanical coupling flat, Maxi or Midi bag with normal outlet
Arm 1: Participants first received the non-Conformité Européene marked test product for 35 -1/+3 days. Then there was a cross-over and the participants received the Conformité Européene comparator product (standard of care) for 35 -1/+3 days.
Arm 2: Participants first received the Conformité Européene marked comparator product for 35 -1/+3 days. Then there was a cross-over and the participants received the non-Conformité Européene test product for 35 -1/+3 days.
|
|---|---|---|
|
Health-related Quality of Life (Scale 0-30)
|
3.2 score on a scale
Interval 2.4 to 4.1
|
4.0 score on a scale
Interval 3.2 to 4.8
|
Adverse Events
Test Product
Serious events: 1 serious events
Other events: 21 other events
Deaths: 1 deaths
Standard of Care
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Total Safety Population
Serious events: 2 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Test Product
n=85 participants at risk
The non-Conformité Européene marked test product is a stoma product based on the flat SenSura® Mio 1-piece and the flat 2-piece with mechanical coupling product that includes a novel skin protective layer in the baseplate.
Arm 1: Participants first received the non-Conformité Européene marked test product for 35 -1/+3 days. Then there was a cross-over and the participants received the Conformité Européene comparator product (standard of care) for 35 -1/+3 days.
Arm 2: Participants first received the Conformité Européene marked comparator product for 35 -1/+3 days. Then there was a cross-over and the participants received the non-Conformité Européene test product for 35 -1/+3 days.
|
Standard of Care
n=79 participants at risk
The following Conformité Européene marked comparator product (standard of care) will be used in this investigation:
* SenSura® Mio 1-piece flat, Midi bag with normal outlet and
* SenSura® Mio 2-piece with mechanical coupling flat, Maxi or Midi bag with normal outlet
Arm 1: Participants first received the non-Conformité Européene marked test product for 35 -1/+3 days. Then there was a cross-over and the participants received the Conformité Européene comparator product (standard of care) for 35 -1/+3 days.
Arm 2: Participants first received the Conformité Européene marked comparator product for 35 -1/+3 days. Then there was a cross-over and the participants received the non-Conformité Européene test product for 35 -1/+3 days.
|
Total Safety Population
n=89 participants at risk
This arm group constitutes the safety population
|
|---|---|---|---|
|
Surgical and medical procedures
Knee injury meniscusresection
|
0.00%
0/85 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.3%
1/79 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.1%
1/89 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
General disorders
Multi organ failure
|
1.2%
1/85 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
0.00%
0/79 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.1%
1/89 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
Other adverse events
| Measure |
Test Product
n=85 participants at risk
The non-Conformité Européene marked test product is a stoma product based on the flat SenSura® Mio 1-piece and the flat 2-piece with mechanical coupling product that includes a novel skin protective layer in the baseplate.
Arm 1: Participants first received the non-Conformité Européene marked test product for 35 -1/+3 days. Then there was a cross-over and the participants received the Conformité Européene comparator product (standard of care) for 35 -1/+3 days.
Arm 2: Participants first received the Conformité Européene marked comparator product for 35 -1/+3 days. Then there was a cross-over and the participants received the non-Conformité Européene test product for 35 -1/+3 days.
|
Standard of Care
n=79 participants at risk
The following Conformité Européene marked comparator product (standard of care) will be used in this investigation:
* SenSura® Mio 1-piece flat, Midi bag with normal outlet and
* SenSura® Mio 2-piece with mechanical coupling flat, Maxi or Midi bag with normal outlet
Arm 1: Participants first received the non-Conformité Européene marked test product for 35 -1/+3 days. Then there was a cross-over and the participants received the Conformité Européene comparator product (standard of care) for 35 -1/+3 days.
Arm 2: Participants first received the Conformité Européene marked comparator product for 35 -1/+3 days. Then there was a cross-over and the participants received the non-Conformité Européene test product for 35 -1/+3 days.
|
Total Safety Population
n=89 participants at risk
This arm group constitutes the safety population
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
1.2%
1/85 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
0.00%
0/79 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.1%
1/89 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Endocrine disorders
Endocrine disorders
|
1.2%
1/85 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
0.00%
0/79 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.1%
1/89 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Eye disorders
Eye disorders
|
0.00%
0/85 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.3%
1/79 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.1%
1/89 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
5.9%
5/85 • Number of events 8 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
6.3%
5/79 • Number of events 6 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
7.9%
7/89 • Number of events 14 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
General disorders
General disorders/adm site conditions
|
1.2%
1/85 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.3%
1/79 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
2.2%
2/89 • Number of events 2 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Infections and infestations
Infections and infestations
|
3.5%
3/85 • Number of events 3 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
3.8%
3/79 • Number of events 3 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
5.6%
5/89 • Number of events 6 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Injury, poisoning and procedural complications
Injury poisoning /procedural complication
|
1.2%
1/85 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.3%
1/79 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
2.2%
2/89 • Number of events 2 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/connective tissue disorders
|
1.2%
1/85 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
5.1%
4/79 • Number of events 5 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
5.6%
5/89 • Number of events 6 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Nervous system disorders
Nervous system disorders
|
2.4%
2/85 • Number of events 2 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
5.1%
4/79 • Number of events 4 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
6.7%
6/89 • Number of events 6 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
1.2%
1/85 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
0.00%
0/79 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.1%
1/89 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory thoracic/mediastinal disorders
|
4.7%
4/85 • Number of events 6 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
2.5%
2/79 • Number of events 2 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
6.7%
6/89 • Number of events 8 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
8.2%
7/85 • Number of events 13 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
6.3%
5/79 • Number of events 8 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
13.5%
12/89 • Number of events 21 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Surgical and medical procedures
Surgical and medical procedure
|
1.2%
1/85 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.3%
1/79 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
2.2%
2/89 • Number of events 2 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
|
Vascular disorders
Vascular disorders
|
1.2%
1/85 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
0.00%
0/79 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
1.1%
1/89 • Number of events 1 • Each subject was enrolled for 2x for 35 -1/+3 days in total for the entire investigation, thus approximately 70 days.
The relationship to the investigational or comparator product were collected. The safety population constituted the subjects who had given informed consent and were 89 participants. The participants in each arm represent an adverse event reported that was either: "Not Related", "Unlikely Related", "Possibly Related", "Probably Related" or "Causal relationship" to the Non-Conformité Eurppéene Marked Product or the Conformité Européene Marked product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the investigation, may be communicated by abstracts, posters, or oral presentations provided that opportunity is given for sponsor to discuss the contents and any conclusions drawn, before the abstract, paper, or visual presentations are finalized. Sponsor will undertake to comment on the draft documents within 30 working days of receipt, but the final decision on the contents and format of the publication from the conclusions drawn, will remain with the authors.
- Publication restrictions are in place
Restriction type: OTHER