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

Institut Paoli-Calmettes141 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

141

Conditions

Colorectal Adenoma

Interventions

FUSE-TM colonoscopeDEVICE

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

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>18 years * Diagnostic colonoscopy Exclusion Criteria: * Colorectal cancer * Colic surgery * Preparation of average or poor quality * Rectal polyp of hyperplastic type \<2 mm

Locations (1)

Institut Paoli Cakmettes

Marseille, Bouches du Rhône, France

Outcomes

Primary Outcomes

Efficacy

Cecal intubation rate

Time frame: 1 day

Efficacy

Absence of necessity to change of endoscope in case of progression, visualization, biopsy or resection

Time frame: 1 day

Secondary Outcomes

Toxicity

Serious adverse events (perforation, uncontrolled bleeding)

Time frame: 1 day

Data from ClinicalTrials.gov

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