Skip to main content
OpenTrials
Completed

NCT Number: NCT03955081

A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Small Bowel Disease

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques universitaires Saint-Luc ASBL, Brussels, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Patients with small bowel disease indicated for deep enteroscopy

Exclusion criteria

  • Age under 18 years
  • Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
  • Any contraindication to standard enteroscopy
  • Concurrent participation in another competing clinical study

Treatment and study plan

Deep enteroscopy

Device

A deep enteroscopy conducted with the new medical device PowerSpiral.

Primary outcomes

  1. Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice.

    Time frame: 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 outcomes

  1. Number of Participants With Therapeutic Yield

    Time frame: up to 12 days

    Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies.

  2. Number of Participants With Procedures That Confirmed Previous Diagnosis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Olympus Europe SE & Co. KG

Industry

Registry information

Official study title

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

Acronym: SAMISEN

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 17, 2019
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.