Clinical trial NCT05129449: A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Lead sponsor: Olympus Europe SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects presenting with surgically altered GI anatomy indicated for ERCP with biliary indication, which fulfil all inclusion and none of the exclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Success Rate. Defined as the Combined Percentage of Enteroscopy Success Rate, Biliary Cannulation Success Rate and Procedural (Therapeutic) Success Rate.
timeFrame: 17 months.
measure: Total Procedure Time
timeFrame: Same day of the ERCP measurement.
measure: Enteroscopy Time
timeFrame: Same day of the ERCP measurement.
measure: (Serious) Adverse Events and Device Deficiencies.
timeFrame: 17 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Duesseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt a.M.
city: Oslo
country: Norway
facility: OUS-Rikshospitalet University Hospital
Study officials:
affiliation: Evangelisches Kranken-haus Düssel-dorf
name: Torsten Beyna, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Tom G. Moreels, Prof.
role: PRINCIPAL_INVESTIGATOR
References: