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NCT03418662

EndoRings Colonoscopy vs Standard Colonoscopy

Completed NA Results posted Last updated 20 September 2019
What this trial tests

NA trial testing EndoRings device in Colorectal Adenoma in 592 participants. Completed in 13 September 2018.

Timeline
19 January 2018
Primary endpoint
13 September 2018
13 September 2018

Quick facts

Lead sponsorIndiana University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposescreening
Enrollment592
Start date19 January 2018
Primary completion13 September 2018
Estimated completion13 September 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Indiana University

Who can join

Eligibility, any sex, with Colorectal Adenoma or Colorectal Polyp. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adenoma Detection Rates Primary · During colonoscopy procedure

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

GroupValue95% CI
EndoRings Colonoscopy143
Control Arm (Standard Colonoscopy)124
Number of Adenomas Per Colonoscopy Primary · During colonoscopy procedure

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

GroupValue95% CI
EndoRings Colonoscopy1.46± 2.69
Control Arm (Standard Colonoscopy)1.06± 1.83
Polyp Detection Rate Secondary · During colonoscopy procedure

Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.

GroupValue95% CI
EndoRings Colonoscopy199
Control Arm (Standard Colonoscopy)188
Number of Detections Per Colonoscopy Secondary · During colonoscopy procedure

Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.

GroupValue95% CI
EndoRings Colonoscopy2.29± 3.09
Control Arm (Standard Colonoscopy)1.82± 2.19
Total Number of Detections Secondary · During colonoscopy procedure

Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.

Polyps
GroupValue95% CI
EndoRings Colonoscopy415
Control Arm (Standard Colonoscopy)295
Adenomas
GroupValue95% CI
EndoRings Colonoscopy650
Control Arm (Standard Colonoscopy)506
Cecal Intubation Rate Secondary · During colonoscopy procedure

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.

GroupValue95% CI
EndoRings Colonoscopy281
Control Arm (Standard Colonoscopy)277
Time Comparison for Each Method Secondary · During colonoscopy procedure

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).

Insertion Time
GroupValue95% CI
EndoRings Colonoscopy6.3± 4.4
Control Arm (Standard Colonoscopy)5.5± 3.4
Total Withdrawal Time
GroupValue95% CI
EndoRings Colonoscopy11.8± 6.1
Control Arm (Standard Colonoscopy)12.8± 5.9
Total Procedure Time
GroupValue95% CI
EndoRings Colonoscopy19.4± 8.2
Control Arm (Standard Colonoscopy)19.5± 7.9
Patient Comfort Score Secondary · After colonoscopy was completed while patient was in recovery area of endoscopy unit

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).

GroupValue95% CI
EndoRings Colonoscopy0.47± 1.1
Control Arm (Standard Colonoscopy)0.36± 0.9
Problems Encountered With Equipment Secondary · During colonoscopy procedure

Occurrences of slippage of EndoRings or of device being removed on insertion.

Procedures with slippage of device
GroupValue95% CI
EndoRings Colonoscopy17
Procedures where device was removed
GroupValue95% CI
EndoRings Colonoscopy25

Sponsor's own description

The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Impact of a ring-fitted cap on insertion time and adenoma detection: a randomized controlled trial.
    Rex DK, Kessler WR, Sagi SV, Rogers NA, et al · · 2020 · cited 14× · PMID 31299257 · DOI 10.1016/j.gie.2019.06.042

Verify or expand the search:

Other recruiting trials for Colorectal Adenoma

Currently open trials in the same condition.

Other Indiana University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03418662.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing