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A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

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: NCT02345889
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas K. Rex, Indiana University

Brief Summary:
Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Device: Colonoscopy with EndoCuff™ Device: FUSE® Colonoscopy Device: Colonoscopy with EndoRings™ Device: Standard Colonoscopy Not Applicable

Detailed Description:
Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
Actual Study Start Date : February 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FUSE® Colonoscopy
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
Device: FUSE® Colonoscopy
colonoscopy performed with the FUSE® (full spectrum endoscopy) system

Active Comparator: Colonoscopy with EndoCuff™
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Device: Colonoscopy with EndoCuff™
colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope

Active Comparator: Colonoscopy with EndoRings™
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Device: Colonoscopy with EndoRings™
colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

Active Comparator: Standard Colonoscopy
A standard colonoscope will be used to complete the procedure
Device: Standard Colonoscopy
Current standard of care colonoscopy




Primary Outcome Measures :
  1. Adenomas Per Colonoscopy [ Time Frame: During Procedure ]

Secondary Outcome Measures :
  1. Number of Participants With Detected Adenoma [ Time Frame: During Procedure ]
  2. Percentage of Participants With Detected Adenoma [ Time Frame: During Procedure ]
  3. Sessile Serrated Polyps Per Colonoscopy [ Time Frame: During Procedure ]
  4. Number of Participants With Detected Sessile Serrated Polyp [ Time Frame: During Procedure ]
    Number of patients with 1 or more sessile serrated polyps

  5. Percentage of Participants With Detected Sessile Serrated Polyp [ Time Frame: During Procedure ]
  6. Number of Participants With a Detected Polyp [ Time Frame: During Procedure ]
  7. Percentage of Participants With a Detected Polyp [ Time Frame: During Procedure ]
  8. Cecal Insertion Time [ Time Frame: During Procedure ]
  9. Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion [ Time Frame: During Procedure ]
  10. Inspection Time [ Time Frame: During Procedure ]
  11. Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. [ Time Frame: During Procedure ]
  12. Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. [ Time Frame: During Procedure ]
  13. Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. [ Time Frame: During Procedure ]
  14. Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. [ Time Frame: During Procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Screening or Surveillance Colonoscopy

Exclusion Criteria:

  • Personal history of Colorectal cancer or Inflammatory bowel disease
  • Surgical resection of the colon or known colonic stricture
  • Personal or family history of Polyposis syndromes or Lynch syndrome
  • Referral for incomplete colonoscopy or known therapeutic polyp clearance
  • Severe diverticular disease
  • Referral for a positive hemoccult test in the past 6 months
  • Known coagulopathy
  • Inability to provide informed consent

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): NCT02345889


Locations
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United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Douglas Rex, MD Indiana University
  Study Documents (Full-Text)

Documents provided by Douglas K. Rex, Indiana University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Douglas K. Rex, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT02345889    
Other Study ID Numbers: 1412036333
First Posted: January 26, 2015    Key Record Dates
Results First Posted: March 12, 2019
Last Update Posted: March 12, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases