Cholangiopancreatography, Endoscopic Retrograde
Conditions
Brief summary
The objective of the SAMISEN study phase B is to assess the performance and safety of diagnostic and therapeutic procedures with the Olympus Motorized Spiral Enteroscope (PowerSpiral) in subjects with surgically altered gastrointestinal anatomy indicated for an Endoscopic Retrograde Cholangio-Pancreatography (ERCP).
Detailed description
The main objective of this registry is to collect data on the safety and performance of the motorized PowerSpiral device during Post-market Clinical Follow-up in subjects with surgically altered gastrointestinal anatomy indicated for an Endoscopic Retrograde Cholangio-Pancreatography (ERCP). It is assumed that this motorized PowerSpiral device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes. As clinical performance and efficacy is equally important for the user this study also collects efficacy and handling data of the motorized PowerSpiral device.
Interventions
Endoscopic Retrograde Cholangio-Pancreatography (ERCP) conducted with motorized PowerSpiral in subjects presenting with surgically altered GI anatomy indicated for ERCP with biliary indication.
Sponsors
Olympus Europe SE & Co. KG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2. Patients with surgically altered upper Gastrointestinal anatomy (Roux-en-Y and Billroth II types) with a biliary indication for ERCP where access with conventional ERCP devices is of no avail and after careful risk assessment.
Exclusion criteria
In addition to be eligible for study enrollment a subject must not meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate. | 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. |
| Total Procedure Time | Same day of the ERCP measurement. | starting with oral insertion until final withdrawal of the device |
| Enteroscopy Time | Same day of the ERCP measurement. | starting with oral insertion until reaching the papilla or the biliary anastomosis |
| (Serious) Adverse Events and Device Deficiencies. | 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 |
Countries
Belgium, Germany, Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 88 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Single Arm Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 22 Participants | — |
| Age, Categorical Between 18 and 65 years | 66 Participants | — |
| Age, Continuous | 58.1 years STANDARD_DEVIATION 15.98 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 35 participants | — |
| Region of Enrollment Germany | 40 participants | — |
| Region of Enrollment Norway | 13 participants | — |
| Sex: Female, Male Female | 37 Participants | — |
| Sex: Female, Male Male | 51 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 88 |
| other Total, other adverse events | 6 / 88 |
| serious Total, serious adverse events | 6 / 88 |
Outcome results
Primary
Enteroscopy Time
starting with oral insertion until reaching the papilla or the biliary anastomosis
Time frame: Same day of the ERCP measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Study | Enteroscopy Time | 29.4 Minutes | Standard Deviation 22 |
Primary
(Serious) Adverse Events and Device Deficiencies.
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
Time frame: 17 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm Study | (Serious) Adverse Events and Device Deficiencies. | Serious Adverse Events (SAE) | 6 Participants |
| Single Arm Study | (Serious) Adverse Events and Device Deficiencies. | Device deficiency | 1 Participants |
| Single Arm Study | (Serious) Adverse Events and Device Deficiencies. | None SAE and devive deficiency | 81 Participants |
Primary
Total Procedure Time
starting with oral insertion until final withdrawal of the device
Time frame: Same day of the ERCP measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Study | Total Procedure Time | 71.1 Minutes | Standard Deviation 42.4 |
Primary
Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate.
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.
Time frame: 17 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm Study | Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate. | 45 Participants |