Trial Outcomes & Findings for A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP) (NCT NCT05129449)
NCT ID: NCT05129449
Last Updated: 2025-03-26
Results Overview
The total success rate refer to the percentage of the following succes rates relevant for ERCP procedures. Combined percentage of Enteroscopy success rate, Biliary Cannulation success rate and Procedural (Therapeutic) success rate.
COMPLETED
89 participants
17 months.
2025-03-26
Participant Flow
Participant milestones
| Measure |
Single Arm Study
All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device.
|
|---|---|
|
Overall Study
STARTED
|
89
|
|
Overall Study
COMPLETED
|
88
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Single Arm Study
All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single Arm Study
n=88 Participants
All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=88 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=88 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=88 Participants
|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 15.98 • n=88 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=88 Participants
|
|
Region of Enrollment
Belgium
|
35 participants
n=88 Participants
|
|
Region of Enrollment
Norway
|
13 participants
n=88 Participants
|
|
Region of Enrollment
Germany
|
40 participants
n=88 Participants
|
PRIMARY outcome
Timeframe: 17 months.The total success rate refer to the percentage of the following succes rates relevant for ERCP procedures. Combined percentage of Enteroscopy success rate, Biliary Cannulation success rate and Procedural (Therapeutic) success rate.
Outcome measures
| Measure |
Single Arm Study
n=88 Participants
All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device.
|
|---|---|
|
Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate.
|
45 Participants
|
PRIMARY outcome
Timeframe: Same day of the ERCP measurement.starting with oral insertion until final withdrawal of the device
Outcome measures
| Measure |
Single Arm Study
n=88 Participants
All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device.
|
|---|---|
|
Total Procedure Time
|
71.1 Minutes
Standard Deviation 42.4
|
PRIMARY outcome
Timeframe: Same day of the ERCP measurement.starting with oral insertion until reaching the papilla or the biliary anastomosis
Outcome measures
| Measure |
Single Arm Study
n=88 Participants
All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device.
|
|---|---|
|
Enteroscopy Time
|
29.4 Minutes
Standard Deviation 22
|
PRIMARY outcome
Timeframe: 17 months.Incidence (% of subjects) and frequency (no. of subjects) with Serious Adverse Events (SAEs) and Device Deficiencies (DD) which meet the severity grading of moderate or severe for the following categories: * Enteroscopy-associated complications (mainly bleeding and perforation(s)) * ERCP-related complications (Dumonceau et al. 2020) * Sedation / anesthesia related complications * other
Outcome measures
| Measure |
Single Arm Study
n=88 Participants
All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device.
|
|---|---|
|
(Serious) Adverse Events and Device Deficiencies.
Serious Adverse Events (SAE)
|
6 Participants
|
|
(Serious) Adverse Events and Device Deficiencies.
Device deficiency
|
1 Participants
|
|
(Serious) Adverse Events and Device Deficiencies.
None SAE and devive deficiency
|
81 Participants
|
Adverse Events
Single Arm Study
Serious adverse events
| Measure |
Single Arm Study
n=88 participants at risk
All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device.
|
|---|---|
|
Gastrointestinal disorders
Bleeding
|
1.1%
1/88 • Number of events 1 • 17 months
|
|
Hepatobiliary disorders
Cholangitis
|
2.3%
2/88 • Number of events 2 • 17 months
|
|
Gastrointestinal disorders
Perforation
|
2.3%
2/88 • Number of events 2 • 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Suspected pulmonary embolism
|
1.1%
1/88 • Number of events 1 • 17 months
|
Other adverse events
| Measure |
Single Arm Study
n=88 participants at risk
All patients received an ERCP examining with the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device.
|
|---|---|
|
Gastrointestinal disorders
Bleeding
|
3.4%
3/88 • Number of events 3 • 17 months
|
|
Gastrointestinal disorders
Pancreatitis
|
2.3%
2/88 • Number of events 2 • 17 months
|
|
Product Issues
Other (System malfunction, non-rotation of spiral before start.)
|
1.1%
1/88 • Number of events 1 • 17 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place