CompletedNot Applicable

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

Belgium, Germany, Norway89 participantsStarted 2022-01-17

Plain-language 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).

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent
✓. 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

✕. Age under 18 years
✕. Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
✕. 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
✕. Concurrent participation in another competing clinical study
✕. Pancreatic indication for ERCP in patient with surgically altered anatomy

What they're measuring

Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate.

Timeframe: 17 months.

Total Procedure Time

Timeframe: Same day of the ERCP measurement.

Enteroscopy Time

Timeframe: Same day of the ERCP measurement.

(Serious) Adverse Events and Device Deficiencies.

Timeframe: 17 months.

Trial details

NCT IDNCT05129449

SponsorOlympus Europe SE & Co. KG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-21

Results submitted2024-07-05

View on ClinicalTrials.gov More Cholangiopancreatography, Endoscopic Retrograde trials

Plain-language summary

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent
✓. 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

✕. Age under 18 years
✕. Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
✕. 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
✕. Concurrent participation in another competing clinical study
✕. Pancreatic indication for ERCP in patient with surgically altered anatomy

What they're measuring

Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate.

Timeframe: 17 months.

Total Procedure Time

Timeframe: Same day of the ERCP measurement.

Enteroscopy Time

Timeframe: Same day of the ERCP measurement.

(Serious) Adverse Events and Device Deficiencies.

Timeframe: 17 months.