Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

NCT03560128 | Completed Results FDA Device

• 1 other identifier: 1802193017
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Adenoma; Colorectal Polyp; Colorectal Cancer

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Number of Adenomas Detected Per Colonoscopy (APC).

  Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.

  During colonoscopy procedure

Secondary Outcomes (7)

• Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))

  During colonoscopy procedure

• Complications Encountered During Procedure

  During Colonoscopy procedure

• Passage of Device Through Sigmoid Colon

  during insertion portion of colonoscopy

• Polyps Per Colonoscopy (PPC)

  During colonoscopy procedure

• Time Comparison for Each Method

  During colonoscopy procedure

Study Arms (2)

Endocuff Vision Arm

EXPERIMENTAL

Colonoscopy with Endocuff Vision device attached to the distal end of the scope.

Device: Endocuff Vision device

AmplifEYE Arm

EXPERIMENTAL

Colonoscopy with AmplifEYE device attached to the distal end of the scope.

Device: AmplifEYE device

Interventions

Endocuff Vision device 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.

Endocuff Vision Arm

AmplifEYE device DEVICE

Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.

AmplifEYE Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Rex DK, Repici A, Gross SA, Hassan C, Ponugoti PL, Garcia JR, Broadley HM, Thygesen JC, Sullivan AW, Tippins WW, Main SA, Eckert GJ, Vemulapalli KC. High-definition colonoscopy versus Endocuff versus EndoRings versus full-spectrum endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial. Gastrointest Endosc. 2018 Aug;88(2):335-344.e2. doi: 10.1016/j.gie.2018.02.043. Epub 2018 Mar 9.

  PMID: 29530353 BACKGROUND

• Rex DK, Sagi SV, Kessler WR, Rogers NA, Fischer M, Bohm ME, Dewitt JM, Lahr RE, Searight MP, Sullivan AW, McWhinney CD, Garcia JR, Broadley HM, Vemulapalli KC. A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial. Gastrointest Endosc. 2019 Nov;90(5):835-840.e1. doi: 10.1016/j.gie.2019.06.046. Epub 2019 Jul 15.

  PMID: 31319060 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Study Coordinator
• Organization: Indiana University

rlahr@iu.edu

317-948-0724

Study Officials

• Douglas K Rex, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 18, 2018
• Study Start: April 12, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)