- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03418662
EndoRings Colonoscopy vs Standard Colonoscopy
A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Arm (Standard Colonoscopy)
Standard colonoscopy with no device attachment.
|
|
Experimental: EndoRings Colonoscopy
Colonoscopy with EndoRings device attached to the distal end of the scope.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adenoma Detection Rates
Time Frame: During colonoscopy procedure
|
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
Time Frame: During colonoscopy procedure
|
Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.
|
During colonoscopy procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Polyp Detection Rate
Time Frame: During colonoscopy procedure
|
Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.
|
During colonoscopy procedure
|
Number of Detections Per Colonoscopy
Time Frame: During colonoscopy procedure
|
Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.
|
During colonoscopy procedure
|
Total Number of Detections
Time Frame: During colonoscopy procedure
|
Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.
|
During colonoscopy procedure
|
Cecal Intubation Rate
Time Frame: 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.
|
During colonoscopy procedure
|
Time Comparison for Each Method
Time Frame: 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). |
During colonoscopy procedure
|
Patient Comfort Score
Time Frame: 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).
|
After colonoscopy was completed while patient was in recovery area of endoscopy unit
|
Problems Encountered With Equipment
Time Frame: During colonoscopy procedure
|
Occurrences of slippage of EndoRings or of device being removed on insertion.
|
During colonoscopy procedure
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1711224972
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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