EndoRings Colonoscopy vs Standard Colonoscopy

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03418662
• Collaborator: US Endoscopy (Industry)
• Enrollment: 592
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.8
• Patients Per Site Per Month: 76

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Adenoma; Colorectal Polyp; Colon Cancer	Device: EndoRings device	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 592 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).
• Actual Study Start Date: Jan 19, 2018
• Actual Primary Completion Date: Sep 13, 2018
• Actual Study Completion Date: Sep 13, 2018

Arms and Interventions

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.	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.

Outcome Measures

Primary Outcome Measures

1. Adenoma Detection Rates [During colonoscopy procedure]

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

2. Number of Adenomas Per Colonoscopy [During colonoscopy procedure]

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

Secondary Outcome Measures

1. Polyp Detection Rate [During colonoscopy procedure]

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

2. Number of Detections Per Colonoscopy [During colonoscopy procedure]

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

3. Total Number of Detections [During colonoscopy procedure]

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

4. Cecal Intubation Rate [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.

5. Time Comparison for Each Method [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).

6. Patient Comfort Score [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).

7. Problems Encountered With Equipment [During colonoscopy procedure]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University
• US Endoscopy

Investigators

• Principal Investigator: Douglas K Rex, MD, Indiana University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 22, 2018

More Information

Publications

None provided.

• Responsible Party: Douglas K. Rex, Professor of Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT03418662
• Other Study ID Numbers: 1711224972
• First Posted: Feb 1, 2018
• Last Update Posted: Sep 20, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Douglas K. Rex, Professor of Medicine, Indiana University: Colonoscopy
• Additional relevant MeSH terms: Adenoma

Study Results

Participant Flow

Recruitment Details	592 patients were enrolled in the study, but 17 were excluded before randomization for not meeting inclusion criteria. 569 patients were randomized.

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.
Period Title: Overall Study
STARTED	287	282
COMPLETED	284	278
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)	Total
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.	Total of all reporting groups
Overall Participants	284	278	562
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.9 (8.1)	61.0 (7.9)	61.5 (9.1)
Sex: Female, Male (Count of Participants)
Female	131 46.1%	142 51.1%	273 48.6%
Male	153 53.9%	136 48.9%	289 51.4%
Race/Ethnicity, Customized (Count of Participants)
White	233 82%	222 79.9%	455 81%
Other	51 18%	56 20.1%	107 19%
Region of Enrollment (participants) [Number]
United States	284 100%	278 100%	562 100%
Indication for Colonoscopy (Count of Participants)
Patients who had a screening colonoscopy	143 50.4%	162 58.3%	305 54.3%
Patients who had a surveillance colonoscopy	141 49.6%	116 41.7%	257 45.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.
Measure Participants	284	278
Count of Participants [Participants]	143 50.4%	124 44.6%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.
Measure Participants	284	278
Mean (Standard Deviation) [adenomas per colonoscopy]	1.46 (2.69)	1.06 (1.83)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.
Measure Participants	284	278
Count of Participants [Participants]	199 70.1%	188 67.6%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.
Measure Participants	284	278
Mean (Standard Deviation) [polyps per colonoscopy]	2.29 (3.09)	1.82 (2.19)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.
Measure Participants	284	278
Polyps	415	295
Adenomas	650	506

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.
Measure Participants	284	278
Count of Participants [Participants]	281 98.9%	277 99.6%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.
Measure Participants	284	278
Insertion Time	6.3 (4.4)	5.5 (3.4)
Total Withdrawal Time	11.8 (6.1)	12.8 (5.9)
Total Procedure Time	19.4 (8.2)	19.5 (7.9)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.
Measure Participants	284	278
Mean (Standard Deviation) [units on a scale]	0.47 (1.1)	0.36 (0.9)

9. Secondary Outcome

Title	Problems Encountered With Equipment
Description	Occurrences of slippage of EndoRings or of device being removed on insertion.
Time Frame	During colonoscopy procedure

Outcome Measure Data

Analysis Population Description

This outcome measure is not applicable for patients randomized to the standard arm because there is no device attached in the standard arm of the study. For this reason, 0 patients are reported for the standard arm for this specific outcome measure.

Arm/Group Title	EndoRings Colonoscopy	Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.	Standard colonoscopy with no device attachment.
Measure Participants	284	0
Procedures with slippage of device	17 6%
Procedures where device was removed	25 8.8%

Adverse Events

Time Frame	During the colonoscopy procedure and while the patient was in the recovery section of the endoscopy suite immediately after the procedure.
Arm/Group Title	EndoRings Colonoscopy		Control Arm (Standard Colonoscopy)
Arm/Group Description	Colonoscopy with EndoRings device attached to the distal end of the scope. 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.		Standard colonoscopy with no device attachment.
All Cause Mortality
	EndoRings Colonoscopy		Control Arm (Standard Colonoscopy)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/284 (0%)		0/278 (0%)
Serious Adverse Events
	EndoRings Colonoscopy		Control Arm (Standard Colonoscopy)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/284 (0%)		0/278 (0%)
Other (Not Including Serious) Adverse Events
	EndoRings Colonoscopy		Control Arm (Standard Colonoscopy)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/284 (0%)		0/278 (0%)

Limitations/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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.