Clinical trial NCT03955081: A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy
Official title: Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Bowel Disease
Lead sponsor: Olympus Europe SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2019-05-17
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with an indication for direct visualization of the small bowel which fulfil all of these inclusion and exclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice.
timeFrame: up to 12 days
Secondary outcomes:
measure: Number of Participants With Therapeutic Yield
timeFrame: up to 12 days
measure: Number of Participants With Procedures That Confirmed Previous Diagnosis
timeFrame: up to 12 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasme,
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc ASBL
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hôpital Edouard Herriot
city: Duesseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Münich
country: Germany
facility: Klinikum rechts der Isar
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach GmbH
city: Oslo
country: Norway
facility: OUS-Rikshospitalet University Hospital
Study officials:
affiliation: Evangelisches Kranken-haus Düssel-dorf
name: Torsten Beyna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beyna T, Moreels T, Arvanitakis M, Pioche M, Saurin JC, May A, Knabe M, Agnholt JS, Bjerregaard NC, Puustinen L, Schlag C, Aabakken L, Paulsen V, Schneider M, Neurath MF, Rath T, Deviere J, Neuhaus H. Motorized spiral enteroscopy: results of an international multicenter prospective observational clinical study in patients with normal and altered gastrointestinal anatomy. Endoscopy. 2022 Dec;54(12):1147-1155. doi: 10.1055/a-1831-6215. Epub 2022 Apr 21.