A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy

Completed

• Conditions: Small Bowel Disease

• Registration Number: NCT03955081
• Lead Sponsor: Olympus Europe SE & Co. KG

Brief Summary

The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).

Detailed Description

The main objective of this registry is to collect data on the safety and performance of the new motorized PowerSpiral device during Post-market Clinical Follow-up. It is assumed that the new 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 new device.

Study Timeline

• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Study Start: 2019-09-02
• Status Verified: 2020-08
• Primary Completion: 2021-03-23
• Study Completion: 2021-05-31
• Results First Submitted: 2022-05-31
• Results First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Results First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

1. Signed informed consent
2. Patients with small bowel disease indicated for deep enteroscopy

Exclusion Criteria

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
4. Concurrent participation in another competing clinical study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice.	up to 12 days	It is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes. Endoscope (PowerSpiral) in a typical clinical setting within the Intended Use

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Therapeutic Yield	up to 12 days	Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies.
Number of Participants With Procedures That Confirmed Previous Diagnosis	up to 12 days	Defined as the percentage of procedures that either confirmed a diagnosis from previous studies, or established a new definitive diagnosis at the anatomical location identified in previous studies or findings that could explain the clinical symptoms.

Trial Locations

Locations (10)

Hôpital Erasme,; 🇧🇪 Brussels, Belgium

Cliniques universitaires Saint-Luc ASBL; 🇧🇪 Bruxelles, Belgium

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Hospices Civils de Lyon, Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Evangelisches Krankenhaus Düsseldorf; 🇩🇪 Duesseldorf, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Klinikum rechts der Isar; 🇩🇪 Münich, Germany

Sana Klinikum Offenbach GmbH; 🇩🇪 Offenbach, Germany

OUS-Rikshospitalet University Hospital; 🇳🇴 Oslo, Norway