EndoRings Colonoscopy vs Standard Colonoscopy

Colon Cancer Clinical Trial

Official title:

A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418662
• Other study ID #: 1711224972
• Status: Completed
• Phase: N/A
• Start date: January 19, 2018
• Est. completion date: September 13, 2018

Study information

• Verified date: September 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: September 13, 2018
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Cancer
• Colorectal Adenoma
• Colorectal Polyp

Intervention

Device:
• EndoRings device
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.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	US Endoscopy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma Detection Rates	Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.	During colonoscopy procedure
Primary	Number of Adenomas Per Colonoscopy	Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.	During colonoscopy procedure
Secondary	Polyp Detection Rate	Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.	During colonoscopy procedure
Secondary	Number of Detections Per Colonoscopy	Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.	During colonoscopy procedure
Secondary	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.	During colonoscopy procedure
Secondary	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.	During colonoscopy procedure
Secondary	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).	During colonoscopy procedure
Secondary	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).	After colonoscopy was completed while patient was in recovery area of endoscopy unit
Secondary	Problems Encountered With Equipment	Occurrences of slippage of EndoRings or of device being removed on insertion.	During colonoscopy procedure