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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02859870
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief 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.

Condition or disease Intervention/treatment
Colorectal Adenoma Device: FUSE-TM colonoscope

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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas
Actual Study Start Date : March 18, 2015
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : April 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy


Intervention Details:
  • Device: FUSE-TM colonoscope
    Colonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator.


Primary Outcome Measures :
  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 Outcome Measures :
  1. Toxicity [ Time Frame: 1 day ]
    Serious adverse events (perforation, uncontrolled bleeding)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with colorectal adenoma candidate to colonoscopy of diagnostic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859870


Locations
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France
Institut Paoli Cakmettes
Marseille, Bouches du Rhône, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Study Director: Jean-Philippe RATONE, MD Institut Paoli-Calmettes

Publications:
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT02859870    
Other Study ID Numbers: FUSE-TM-Colon-IPC 2015-002
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms