NCT03418662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
592

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

January 19, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 20, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

January 2, 2018

Results QC Date

July 30, 2019

Last Update Submit

September 18, 2019

Conditions

Colorectal AdenomaColorectal PolypColon Cancer

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (2)

  • Adenoma Detection Rates

    Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.

    During colonoscopy procedure

  • Number of Adenomas Per Colonoscopy

    Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.

    During colonoscopy procedure

Secondary Outcomes (7)

  • Polyp Detection Rate

    During colonoscopy procedure

  • Number of Detections Per Colonoscopy

    During colonoscopy procedure

  • Total Number of Detections

    During colonoscopy procedure

  • Cecal Intubation Rate

    During colonoscopy procedure

  • Time Comparison for Each Method

    During colonoscopy procedure

  • +2 more secondary outcomes

Study Arms (2)

Control Arm (Standard Colonoscopy)

NO INTERVENTION

Standard colonoscopy with no device attachment.

EndoRings Colonoscopy

EXPERIMENTAL

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

Device: EndoRings device

Interventions

EndoRings deviceDEVICE

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.

EndoRings Colonoscopy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 31299257DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Limitations and Caveats

Single center design; Inability to blind endoscopists to device randomization; Most patients were sedated with propofol so it would not reasonably be expected to have a difference in patient comfort score

Results Point of Contact

Title
Rachel Lahr
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

January 2, 2018

First Posted

February 1, 2018

Study Start

January 19, 2018

Primary Completion

September 13, 2018

Study Completion

September 13, 2018

Last Updated

September 20, 2019

Results First Posted

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

De-identified data may be shared upon the discretion of the principal investigator.

Locations

US(1)