Skip to main content
OpenTrials
Completed

NCT Number: NCT02859870

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Adenoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Paoli Cakmettes

Marseille, Bouches du Rhône, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FUSE-TM colonoscope

Device

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

Primary outcomes

  1. Efficacy

    Time frame: 1 day

    Cecal intubation rate

  2. Efficacy

    Time frame: 1 day

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

Secondary outcomes

  1. Toxicity

    Time frame: 1 day

    Serious adverse events (perforation, uncontrolled bleeding)

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: FUSETM-Colon

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 9, 2016
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.