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EndoRings Colonoscopy vs Standard Colonoscopy

Primary Purpose

Colorectal Adenoma, Colorectal Polyp, Colon Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EndoRings 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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Screening or Surveillance Colonoscopy
  • Able to provide written informed consent

Exclusion Criteria:

  • Known narrow colon or colon stenosis
  • Personal history of Colorectal cancer
  • History of inflammatory bowel disease
  • Familial adenomatous polyposis syndrome (FAP)
  • Hyperplastic polyposis syndrome
  • Referral for incomplete colonoscopy or polyp clearance

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Arm (Standard Colonoscopy)

EndoRings Colonoscopy

Arm Description

Standard colonoscopy with no device attachment.

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

Outcomes

Primary Outcome Measures

Adenoma Detection Rates
Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
Number of Adenomas Per Colonoscopy
Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.

Secondary Outcome Measures

Polyp Detection Rate
Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.
Number of Detections Per Colonoscopy
Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.
Total Number of Detections
Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.
Cecal Intubation Rate
Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy.
Time Comparison for Each Method
Comparison of the time required to reach the cecum, withdrawal time, and total procedure time. Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps. Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal).
Patient Comfort Score
Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome).
Problems Encountered With Equipment
Occurrences of slippage of EndoRings or of device being removed on insertion.

Full Information

First Posted
January 2, 2018
Last Updated
September 18, 2019
Sponsor
Indiana University
Collaborators
US Endoscopy
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1. Study Identification

Unique Protocol Identification Number
NCT03418662
Brief Title
EndoRings Colonoscopy vs Standard Colonoscopy
Official Title
A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
September 13, 2018 (Actual)
Study Completion Date
September 13, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.
Detailed Description
This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma, Colorectal Polyp, Colon 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
592 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm (Standard Colonoscopy)
Arm Type
No Intervention
Arm Description
Standard colonoscopy with no device attachment.
Arm Title
EndoRings Colonoscopy
Arm Type
Experimental
Arm Description
Colonoscopy with EndoRings device attached to the distal end of the scope.
Intervention Type
Device
Intervention Name(s)
EndoRings device
Intervention Description
Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.
Primary Outcome Measure Information:
Title
Adenoma Detection Rates
Description
Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
Time Frame
During colonoscopy procedure
Title
Number of Adenomas Per Colonoscopy
Description
Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.
Time Frame
During colonoscopy procedure
Secondary Outcome Measure Information:
Title
Polyp Detection Rate
Description
Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.
Time Frame
During colonoscopy procedure
Title
Number of Detections Per Colonoscopy
Description
Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.
Time Frame
During colonoscopy procedure
Title
Total Number of Detections
Description
Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.
Time Frame
During colonoscopy procedure
Title
Cecal Intubation Rate
Description
Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy.
Time Frame
During colonoscopy procedure
Title
Time Comparison for Each Method
Description
Comparison of the time required to reach the cecum, withdrawal time, and total procedure time. Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps. Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal).
Time Frame
During colonoscopy procedure
Title
Patient Comfort Score
Description
Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome).
Time Frame
After colonoscopy was completed while patient was in recovery area of endoscopy unit
Title
Problems Encountered With Equipment
Description
Occurrences of slippage of EndoRings or of device being removed on insertion.
Time Frame
During colonoscopy procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Screening or Surveillance Colonoscopy Able to provide written informed consent Exclusion Criteria: Known narrow colon or colon stenosis Personal history of Colorectal cancer History of inflammatory bowel disease Familial adenomatous polyposis syndrome (FAP) Hyperplastic polyposis syndrome Referral for incomplete colonoscopy or polyp clearance
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 may be shared upon the discretion of the principal investigator.
Citations:
PubMed Identifier
31299257
Citation
Rex DK, Kessler WR, Sagi SV, Rogers NA, Fischer M, Bohm ME, Wo JM, Dewitt JM, McHenry L, Lahr RE, Searight MP, MacPhail M, Sullivan AW, McWhinney CD, Vemulapalli KC. Impact of a ring-fitted cap on insertion time and adenoma detection: a randomized controlled trial. Gastrointest Endosc. 2020 Jan;91(1):115-120. doi: 10.1016/j.gie.2019.06.042. Epub 2019 Jul 9.
Results Reference
derived

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EndoRings Colonoscopy vs Standard Colonoscopy

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