Clinical Trials Directory

Trials / Completed

CompletedNCT02859870

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

Status
Completed
Phase
Study type
Observational
Enrollment
141 (actual)
Sponsor
Institut Paoli-Calmettes · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEFUSE-TM colonoscopeColonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator.

Timeline

Start date
2015-03-18
Primary completion
2016-04-30
Completion
2016-04-30
First posted
2016-08-09
Last updated
2017-08-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02859870. Inclusion in this directory is not an endorsement.