CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 141 enrolled
Drug / intervention
FUSE-TM colonoscopedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02859870
NCT02859870N/ACompleted

Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas

Institut Paoli-Calmettes·observational·Posted Aug 9, 2016·Updated Aug 21, 2017

In Brief

An observational study evaluating FUSE-TM colonoscope for Colorectal Adenoma. Completed, enrolled 141 participants across 1 site.

Detailed Summary

The coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. However the literature reports that the rate of omitted adenoma is still high (24 to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. This first study in France concerning this technology has the objectives to demonstrate the feasibility in France, the safety and to compare the rate of detected adenomas with data of the literature.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 9, 2016
Enrollment StartMar 18, 2015
Primary CompletionApr 30, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.9 years ago

Interventions

FUSE-TM colonoscopedevice

Colonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator.