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Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

Primary Purpose

Colorectal Adenoma, Colorectal Polyp, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endocuff Vision device
AmplifEYE device
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Adenoma focused on measuring Colonoscopy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Endocuff Vision Arm

AmplifEYE Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))
Comparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Complications Encountered During Procedure
Comparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.
Passage of Device Through Sigmoid Colon
Comparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.
Polyps Per Colonoscopy (PPC)
Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Time Comparison for Each Method
Comparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps. Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps. Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope.
Cecal Intubation Rate
Comparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy.
Detection of Serrated Lesions
Comparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.

Full Information

First Posted
June 6, 2018
Last Updated
September 20, 2019
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03560128
Brief Title
Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy
Official Title
Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
December 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma, Colorectal Polyp, Colorectal Cancer
Keywords
Colonoscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
634 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endocuff Vision Arm
Arm Type
Experimental
Arm Description
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Arm Title
AmplifEYE Arm
Arm Type
Experimental
Arm Description
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
Intervention Type
Device
Intervention Name(s)
Endocuff Vision device
Intervention Description
Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
Intervention Type
Device
Intervention Name(s)
AmplifEYE device
Intervention Description
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 Measure Information:
Title
Number of Adenomas Detected Per Colonoscopy (APC).
Description
Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Time Frame
During colonoscopy procedure
Secondary Outcome Measure Information:
Title
Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))
Description
Comparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Time Frame
During colonoscopy procedure
Title
Complications Encountered During Procedure
Description
Comparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.
Time Frame
During Colonoscopy procedure
Title
Passage of Device Through Sigmoid Colon
Description
Comparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.
Time Frame
during insertion portion of colonoscopy
Title
Polyps Per Colonoscopy (PPC)
Description
Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Time Frame
During colonoscopy procedure
Title
Time Comparison for Each Method
Description
Comparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps. Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps. Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope.
Time Frame
During colonoscopy procedure
Title
Cecal Intubation Rate
Description
Comparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy.
Time Frame
During Colonoscopy procedure
Title
Detection of Serrated Lesions
Description
Comparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Time Frame
During colonoscopy procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas K Rex, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data can be shared in the future upon request.
Citations:
PubMed Identifier
29530353
Citation
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.
Results Reference
background
PubMed Identifier
31319060
Citation
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.
Results Reference
derived

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Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

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