A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

— SAMISEN-B  

Official title:

Safety and Performance of the Motorized Spiral Endoscope PowerSpiral in Subjects Indicated for Small-bowel Enteroscopy or Endoscopic Retrograde Cholangio-Pancreatography (ERCP) in Subjects With Surgically Altered Gastrointestinal Anatomy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05129449
• Other study ID #: 2018-GI (OEKG) - 01 Phase B
• Status: Terminated
• Start date: January 17, 2022
• Est. completion date: June 21, 2023

Study information

• Verified date: March 2023
• Source: Olympus Europe SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: June 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 exclusion criteria listed below.

1. Age under 18 years

2. Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period

3. Any contraindication to standard enteroscopy or ERCP (e.g. severe coagulopathy or known coagulation disorder; bowel obstruction / stenosis, stents or other instruments implanted in the intestinal tract, suspected GI perforation, esophageal or gastric varices, eosinophilic esophagitis) as judged by the investigator after careful individual risk assessment

4. Concurrent participation in another competing clinical study

5. Pancreatic indication for ERCP in patient with surgically altered anatomy

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde

Intervention

Device:
• Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Endoscopic Retrograde Cholangio-Pancreatography (ERCP) conducted with motorized PowerSpiral in subjects presenting with surgically altered GI anatomy indicated for ERCP with biliary indication.

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Brussels
Belgium	Cliniques universitaires Saint-Luc	Bruxelles
Germany	Evangelisches Krankenhaus Düsseldorf	Duesseldorf
Germany	University Hospital Frankfurt a.M.	Frankfurt
Norway	OUS-Rikshospitalet University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Europe SE & Co. KG

Countries where clinical trial is conducted

Belgium,  Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total success rate	Defined as the combined percentage of Enteroscopy success rate, Biliary Cannulation success rate and Procedural (Therapeutic) success rate.	up to 12 days
Primary	Total procedure time	starting with oral insertion until final withdrawal of the device	up to 12 days
Primary	Enteroscopy time	starting with oral insertion until reaching the papilla or the biliary anastomosis	up to 12 days
Primary	Collect Serious Adverse Events and Device Deficiencies to demonstrate safety of the Motorized Spiral Endoscope (PowerSpiral) in daily medical practice.	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	up to 12 days