Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date August 2, 2016
First Posted Date August 9, 2016
Last Update Posted Date August 21, 2017
Actual Study Start Date March 18, 2015
Actual Primary Completion Date April 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 4, 2016)
  • Efficacy [ Time Frame: 1 day ]
    Cecal intubation rate
  • Efficacy [ Time Frame: 1 day ]
    Absence of necessity to change of endoscope in case of progression, visualization, biopsy or resection
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 4, 2016)
Toxicity [ Time Frame: 1 day ]
Serious adverse events (perforation, uncontrolled bleeding)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas
Official Title Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with colorectal adenoma candidate to colonoscopy of diagnostic
Condition Colorectal Adenoma
Intervention Device: FUSE-TM colonoscope
Colonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 16, 2017)
141
Original Estimated Enrollment
 (submitted: August 4, 2016)
131
Actual Study Completion Date April 30, 2016
Actual Primary Completion Date April 30, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02859870
Other Study ID Numbers FUSE-TM-Colon-IPC 2015-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Institut Paoli-Calmettes
Study Sponsor Institut Paoli-Calmettes
Collaborators Not Provided
Investigators
Study Director: Jean-Philippe RATONE, MD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date August 2017