A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy

Olympus Europe SE & Co. KG302 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

302

Conditions

Small Bowel Disease

Interventions

Deep enteroscopyDEVICE

A deep enteroscopy conducted with the new medical device PowerSpiral.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (10)

Cliniques universitaires Saint-Luc ASBL

Brussels, Belgium

Hôpital Erasme,

Brussels, Belgium

Aarhus University Hospital

Aarhus N, Denmark

Helsinki University Central Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

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

Time frame: up to 12 days

Secondary Outcomes

Number of Participants With Therapeutic Yield

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

Time frame: up to 12 days

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.

Time frame: up to 12 days

Data from ClinicalTrials.gov

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