Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03361917
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 47.6

Study Details

Study Description

Brief Summary

This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

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

Detailed Description

For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times
• Actual Study Start Date: Dec 11, 2017
• Actual Primary Completion Date: Apr 18, 2018
• Actual Study Completion Date: Apr 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Arm (Standard Colonscopy) Standard colonoscopy with no device attachments
Experimental: Endocuff Vision Colonoscopy with Endocuff Vision attached to distal end of scope	Device: Endocuff Vision; Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.

Outcome Measures

Primary Outcome Measures

1. Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) [During the withdrawal portion of the colonoscopy procedure]

   Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.

Secondary Outcome Measures

1. Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision) [During the insertion portion of the colonoscopy procedure]

   Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.

2. Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision) [During the colonoscopy procedure]

   Total procedure time is the time from the initial insertion through the complete withdrawal of the scope

3. Detection Rates [During the colonoscopy procedure]

   The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.

4. Polyps Per Colonoscopy [During the colonoscopy procedure]

   Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.

5. Boston Bowel Preparation Score [During the withdrawal portion of the colonoscopy procedure after cleaning of the colon]

   Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. The quality of the bowel preparation is assessed by the attending gastroenterologist.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject referred for a screening or surveillance colonoscopy

• Subject is aged 40 years or older

• Subject has the ability to provide informed consent

Exclusion Criteria:

• Prior history of colon cancer

• History of inflammatory bowel disease

• Prior surgical resection of any part of the colon

• Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure

• History of polyposis syndrome or HNPCC

• Family history of colon cancer in a first-degree relative < 60 years or two first degree relatives with colorectal cancer

• Inability to provide informed consent

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Indiana University

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 10, 2018

More Information

Publications

• Tsiamoulos ZP, Misra R, Rameshshanker R, Elliott TR, Beintaris I, Thomas-Gibson S, Haycock A, Suzuki N, Rees C, Saunders BP. Impact of a new distal attachment on colonoscopy performance in an academic screening center. Gastrointest Endosc. 2018 Jan;87(1):280-287. doi: 10.1016/j.gie.2017.04.001. Epub 2017 Apr 13.

• Responsible Party: Douglas K. Rex, Distinguished Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT03361917
• Other Study ID Numbers: 1709336500; NCT03398447
• First Posted: Dec 5, 2017
• Last Update Posted: Aug 6, 2019
• Last Verified: Jul 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.: No
• Keywords provided by Douglas K. Rex, Distinguished Professor, Indiana University: Colonoscopy screening; Colonscopy procedure
• Additional relevant MeSH terms: Adenoma

Study Results

Participant Flow

Arm/Group Title	Control Arm (Standard Colonscopy)	Endocuff Vision
Arm/Group Description	Standard colonoscopy with no device attachments	Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.
Period Title: Overall Study
STARTED	99	101
COMPLETED	99	101
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Endocuff Vision	Control Arm (Standard Colonscopy)	Total
Arm/Group Description	Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Standard colonoscopy with no device attachments	Total of all reporting groups
Overall Participants	101	99	200
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	62.7 (8.9)	61.7 (9.9)	62.2 (9.4)
Sex: Female, Male (Count of Participants)
Female	44 43.6%	57 57.6%	101 50.5%
Male	57 56.4%	42 42.4%	99 49.5%
Race/Ethnicity, Customized (Count of Participants)
White	87 86.1%	92 92.9%	179 89.5%
Other	14 13.9%	7 7.1%	21 10.5%
Region of Enrollment (participants) [Number]
United States	101 100%	99 100%	200 100%
Gastroenterology fellows assisting in insertion (Count of Participants)
Count of Participants [Participants]	17 16.8%	15 15.2%	32 16%
Procedure Indication (Count of Participants)
Screening	45 44.6%	52 52.5%	97 48.5%
Surveillance	56 55.4%	47 47.5%	103 51.5%

Outcome Measures

1. Primary Outcome

Title	Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Description	Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.
Time Frame	During the withdrawal portion of the colonoscopy procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endocuff Vision	Control Arm (Standard Colonscopy)
Arm/Group Description	Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Standard colonoscopy with no device attachments
Measure Participants	101	99
Mean (Standard Error) [Minutes]	6.49 (.10)	8.42 (0.12)

2. Secondary Outcome

Title	Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Description	Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.
Time Frame	During the insertion portion of the colonoscopy procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endocuff Vision	Control Arm (Standard Colonscopy)
Arm/Group Description	Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Standard colonoscopy with no device attachments
Measure Participants	101	99
Mean (Standard Error) [Minutes]	4.05 (0.16)	4.42 (0.19)

3. Secondary Outcome

Title	Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Description	Total procedure time is the time from the initial insertion through the complete withdrawal of the scope
Time Frame	During the colonoscopy procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endocuff Vision	Control Arm (Standard Colonscopy)
Arm/Group Description	Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Standard colonoscopy with no device attachments
Measure Participants	101	99
Mean (Standard Deviation) [Minutes]	21.01 (6.8)	21.24 (7.8)

4. Secondary Outcome

Title	Detection Rates
Description	The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.
Time Frame	During the colonoscopy procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endocuff Vision	Control Arm (Standard Colonscopy)
Arm/Group Description	Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Standard colonoscopy with no device attachments
Measure Participants	101	99
Adenomas	61.4 60.8%	52.5 53%
Sessile serrated polyps	19.8 19.6%	11.1 11.2%

5. Secondary Outcome

Title	Polyps Per Colonoscopy
Description	Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.
Time Frame	During the colonoscopy procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endocuff Vision	Control Arm (Standard Colonscopy)
Arm/Group Description	Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Standard colonoscopy with no device attachments
Measure Participants	101	99
Adenomas	1.43 (1.79)	1.07 (1.62)
Sessile serrated polyps	0.27 (0.63)	0.21 (0.70)

6. Secondary Outcome

Title	Boston Bowel Preparation Score
Description	Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. The quality of the bowel preparation is assessed by the attending gastroenterologist.
Time Frame	During the withdrawal portion of the colonoscopy procedure after cleaning of the colon

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endocuff Vision	Control Arm (Standard Colonscopy)
Arm/Group Description	Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Standard colonoscopy with no device attachments
Measure Participants	101	99
Median (Full Range) [Scores on a scale]	9	9

Adverse Events

Time Frame	5 months
Arm/Group Title	Control Arm (Standard Colonscopy)		Endocuff Vision
Arm/Group Description	Standard colonoscopy with no device attachments		Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.
All Cause Mortality
	Control Arm (Standard Colonscopy)		Endocuff Vision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/101 (0%)
Serious Adverse Events
	Control Arm (Standard Colonscopy)		Endocuff Vision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/101 (0%)
Other (Not Including Serious) Adverse Events
	Control Arm (Standard Colonscopy)		Endocuff Vision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/101 (0%)

Limitations/Caveats

Examiners were not blinded to the device used. Only 2 examiners with experience with the device participated in the study so generalizability of the results is unknown. Data was not collected on other potential confounders like smoking or BMI.

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.