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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05129449
Other study ID # 2018-GI (OEKG) - 01 Phase B
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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