A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy

Small Bowel Disease Clinical Trial

— SAMISEN  

Official title:

Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955081
• Other study ID #: 2018-GI (OEKG) - 01
• Status: Completed
• Start date: September 2, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2020
• Source: Olympus Europe SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: May 31, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Diseases
• Small Bowel Disease

Intervention

Device:
• Deep enteroscopy
A deep enteroscopy conducted with the new medical device PowerSpiral.

Locations

Country	Name	City	State
Belgium	Hôpital Erasme,	Brussels
Belgium	Cliniques universitaires Saint-Luc ASBL	Bruxelles
Denmark	Aarhus University Hospital	Aarhus N
Finland	Helsinki University Central Hospital	Helsinki
France	Hospices Civils de Lyon, Hôpital Edouard Herriot	Lyon
Germany	Evangelisches Krankenhaus Düsseldorf	Duesseldorf
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Klinikum rechts der Isar	Münich
Germany	Sana Klinikum Offenbach GmbH	Offenbach
Norway	OUS-Rikshospitalet University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Europe SE & Co. KG

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  France,  Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice.	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	up to 12 days
Secondary	Number of Participants With Therapeutic Yield	Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies.	up to 12 days
Secondary	Number of Participants With Procedures That Confirmed Previous Diagnosis	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.	up to 12 days