Trial Outcomes & Findings for A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use (NCT NCT02746406)
NCT ID: NCT02746406
Last Updated: 2017-01-11
Results Overview
Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group
COMPLETED
NA
5 participants
Through study completion, an average of 4 days
2017-01-11
Participant Flow
Participant milestones
| Measure |
Peritron+
SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter
Peritron+: Peritron+ device to measure intravesical pressure
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use
Baseline characteristics by cohort
| Measure |
Peritron+
n=5 Participants
SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter
Peritron+: Peritron+ device to measure intravesical pressure
|
|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Gender
Female
|
2 Participants
n=99 Participants
|
|
Gender
Male
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 4 daysEach participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group
Outcome measures
| Measure |
Peritron+
n=5 Participants
SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter
Peritron+: Peritron+ device to measure intravesical pressure
|
|---|---|
|
Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.
|
65 participants
|
Adverse Events
Peritron+
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor can review results communications prior to public release regarding trial results for a period that is less than 60 days. The sponsor can request changes to the communication.
- Publication restrictions are in place
Restriction type: OTHER