A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy (SAMISEN)

Olympus

Status: Completed

Conditions: Small Bowel Disease

Treatments: Device: Deep enteroscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT03955081

2018-GI (OEKG) - 01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 302 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design