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Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

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ClinicalTrials.gov Identifier: NCT03560128
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Douglas K. Rex, Indiana University

Brief Summary:
The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.

Condition or disease Intervention/treatment Phase
Colorectal Adenoma Colorectal Polyp Colorectal Cancer Device: Endocuff Vision device Device: AmplifEYE device Not Applicable

Detailed Description:

This will be a prospective, randomized controlled study. Subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy and an AmplifEYE colonoscopy.

It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators consider that a clinically acceptable ADR for the Medivators device would be within 20% of this value or 1.5.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Endocuff Vision Arm
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Device: Endocuff Vision device
Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.

Experimental: AmplifEYE Arm
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
Device: AmplifEYE device
Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.




Primary Outcome Measures :
  1. Number of Adenomas Detected per Colonoscopy (APC). [ Time Frame: 1 day ]
    Comparison of the number of adenomas detected per colonoscopy between the Endocuff Colonoscopy and the AmplifEYE colonoscopy.


Secondary Outcome Measures :
  1. Detection Rates (ADR and PDR) [ Time Frame: 1 day ]
    Comparison of the number of adenomas (ADR) and number of polyps (PDR) detected per subject between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.

  2. Complications encountered during procedure [ Time Frame: 1 day ]
    Comparison of amount of mucosal trauma, perforation, or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.

  3. Passage of device through Sigmoid Colon [ Time Frame: 1 day ]
    Comparison of how easily device is passed through the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.

  4. Polyps per Colonoscopy (PPC) [ Time Frame: 1 day ]
    Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.

  5. Time Comparison for Each Method [ Time Frame: 1 day ]
    Comparison of the time required to reach the cecum, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.

  6. Cecal Intubation Rate [ Time Frame: 1 day ]
    Comparison of cecal intubation rate between AmplifEYE colonoscopy and Endocuf Vision colonoscopy.

  7. Detection of Serrated and Flat lesions [ Time Frame: 1 day ]
    Comparison of the serrated lesions and the flat lesions detected between the Endocuff Vision colonoscopy and the AmplifEYE colonoscopy.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 40 years of age or older
  • Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
  • Able to provide written informed consent

Exclusion Criteria:

  • Active Inflammatory Bowel Disease
  • Prior resection of the colon
  • Referred for resection of a polyp identified by another physician
  • Referred for a previous incomplete colonoscopy

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): NCT03560128


Contacts
Contact: Jonathan Garcia 317-948-0117 garciajr@iu.edu

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jonathan Garcia    317-948-0117    garciajr@iu.edu   
Contact: Rachel Lahr    317-948-0724    rlahr@iu.edu   
Principal Investigator: Douglas K Rex, MD         
Sponsors and Collaborators
Indiana University

Publications:
Responsible Party: Douglas K. Rex, Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03560128     History of Changes
Other Study ID Numbers: 1802193017
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD sharing plan will be determined based on the outcome of the initial data analysis.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Douglas K. Rex, Indiana University:
Colonoscopy

Additional relevant MeSH terms:
Colonic Diseases
Colorectal Neoplasms
Polyps
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type