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

Olympus Europe SE & Co. KG89 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Interventions

Endoscopic Retrograde Cholangio-Pancreatography (ERCP)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (5)

Cliniques universitaires Saint-Luc

Brussels, Belgium

Hôpital Erasme

Brussels, Belgium

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

University Hospital Frankfurt a.M.

Frankfurt, Germany

Outcomes

Primary Outcomes

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.

Total Procedure Time

starting with oral insertion until final withdrawal of the device

Time frame: Same day of the ERCP measurement.

Enteroscopy Time

starting with oral insertion until reaching the papilla or the biliary anastomosis

Time frame: Same day of the ERCP measurement.

(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.

Data from ClinicalTrials.gov

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