NCT03955081: SAMISEN

A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy

Completed Results posted Last updated 30 January 2024

What this trial tests

trial testing Deep enteroscopy in Small Bowel Disease in 302 participants. Completed in 31 May 2021.

Timeline

2 September 2019

Primary endpoint
23 March 2021

31 May 2021

Quick facts

Lead sponsor	Olympus Europe SE & Co. KG
Status	Completed
Study type	OBSERVATIONAL
Enrollment	302
Start date	2 September 2019
Primary completion	23 March 2021
Estimated completion	31 May 2021
Sites	10 locations across Denmark, France, Finland, Belgium, Germany, Norway

Drugs / interventions tested

• Deep enteroscopy

Conditions studied

• Small Bowel Disease — all drugs for Small Bowel Disease →

Sponsor

Olympus Europe SE & Co. KG — full company profile →

Who can join

Adults 18 to 90, any sex, with Small Bowel Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Serious Adverse Events

Group	Value	95% CI
Single Arm	6

Device Deficiencies

Group	Value	95% CI
Single Arm	1

Number of Participants With Therapeutic Yield Secondary · up to 12 days

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

Group	Value	95% CI
Single Arm	172

Number of Participants With Procedures That Confirmed Previous Diagnosis Secondary · 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.

Group	Value	95% CI
Single Arm	251

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected during the whole study duration of approx. 18 months and for each individual patients from signing the consent until hospital discharge.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Arm

Serious: 7/298 (2%)

Deaths: 7/298

Serious adverse events (5 terms)

Reaction	System	Single Arm
Perforation	Gastrointestinal disorders	—
Bleeding	Gastrointestinal disorders	—
Mucosal injury	Gastrointestinal disorders	—
Complications associated with sedation/anesthesia	General disorders	—
Other	Gastrointestinal disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Single Arm
Bleeding	Gastrointestinal disorders	—
Laceration	Gastrointestinal disorders	—

Most-reported serious reactions: Perforation, Bleeding, Mucosal injury, Complications associated with sedation/anesthesia, Other.

Data from ClinicalTrials.gov NCT03955081 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 
   · 2021 · PMID 34813177 · DOI 10.1002/ueg2.12172