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Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary

Primary Purpose

Colorectal Cancer, Colonic Polyps

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Use of Endocuff during colonoscopy
Sponsored by
Hopital Montfort
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Endocuff, Retroflexion, Colonoscopy, Polyp detection, Screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Any patient undergoing a colonoscopy during the study period Procedure being performed by a gastroenterologist (i.e., surgeons are excluded) Exclusion Criteria: Inflammatory Bowel Disease Hereditary Mixed Polyposis Syndrome Diverticulitis Colonic stricture Toxic Megacolon Previous Colon surgery, excluding appendectomy Radiation therapy to abdomen or pelvis Pregnancy/Lactation Anticoagulant use Suffered stroke or ischemia in previous 3 months Being deemed too risky by investigator FIT positive Poor preparation

Sites / Locations

  • Hopital MontfortRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Colonoscopy without Endocuff

Colonoscopy with Endocuff

Arm Description

No Endocuff inserted proximally to colonoscope and use of retroflexion

Endocuff inserted proximally to colonoscope, no use of retroflexion

Outcomes

Primary Outcome Measures

Increase in Polyp Detection Rates when using the Endocuff Enhanced Colonoscopy.
Comparing Polyp Detection Rate when using the Endocuff Enhanced Colonoscopy to retrospective conventional colonoscopy.
Number of participants endorsing a comfortable procedure when using the Endocuff assisted colonoscopy assessed by Numerical Rating Scale (NRS).
Results of Numerical Rating Scale pain score when evaluating the rectum with the Endocuff.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2022
Last Updated
February 28, 2023
Sponsor
Hopital Montfort
Collaborators
AFP Innovation Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05615857
Brief Title
Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary
Official Title
Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Montfort
Collaborators
AFP Innovation Fund

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators hope that this project will determine if the Endocuff device is a useful adjunct during colonoscopy by optimizing polyp detection and eliminating the need for the painful rectal retroflexion. As such, by improving polyp detection and eliminating the need for rectal retroflexion, it will directly reduce the likelihood of colon cancer and improve patient comfort respectively.
Detailed Description
Every day, 73 Canadians are diagnosed with colorectal cancer. This cancer is the third most diagnosed type of cancer in Canada while being the second and third most deadly cancer for men and women respectively. In addition, it accounts for 12% of all cancer diagnoses and cancer deaths for both sexes in 2020. Fortunately, colorectal cancer incidence and mortality rates have been steadily declining in the recent years. This can be attributed to the development of new screening methods and devices assisting in a more reliable identification of polyps as well as removal during colonoscopy. This is essential to prevent cancer as these usually asymptomatic and harmless clusters of atypical cells can turn into cancers, and become fatal if they can progress to a later stage of their development. The Endocuff is a new colonoscopy assisting device designed to aid physicians to maneuver inside the colon, allowing for increased detection of polyps that stay hidden between folds in the colon. By its flexible and hinged arms, the Endocuff is designed to gently flatten the large colonic folds during withdrawal of the colonoscope, bringing the difficult-to-see mucosa to view. The Endocuff also may assist in the view of the rectum, being the last area of the colon and difficult to assess. Usually, a painful procedure called a retroflexion is used to help see this area. However, this pain can limit the evaluation and impact polyp diagnosis in the rectum. In this study, the investigators aspire to answer these following questions: (1) Can the Endocuff improve polyp detection? (2) Can the Endocuff replace the need for retroflexion in the rectum?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colonic Polyps
Keywords
Endocuff, Retroflexion, Colonoscopy, Polyp detection, Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We are to count the number of adenomas and polyps identified per patient while using the Endocuff. These numbers will be compared to the number of identified adenomas and polyps found without the use of the Endocuff retrospectively. In addition, the number of adenomas and polyps found in the rectum while using the Endocuff will be compared to the numbers of adenomas and polyps found with retroflexion without the use of Endocuff. Once the colonoscopy is complete, the patient's level of comfort during the procedure will be documented.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colonoscopy without Endocuff
Arm Type
No Intervention
Arm Description
No Endocuff inserted proximally to colonoscope and use of retroflexion
Arm Title
Colonoscopy with Endocuff
Arm Type
Experimental
Arm Description
Endocuff inserted proximally to colonoscope, no use of retroflexion
Intervention Type
Device
Intervention Name(s)
Use of Endocuff during colonoscopy
Intervention Description
We will be adding the Endocuff device to the proximal end of the colonoscope, adding an additional tool to facilitate the visualization of the difficult-to-see mucosal areas as well as the rectum. There will be no need for retroflexion to evaluate the colon
Primary Outcome Measure Information:
Title
Increase in Polyp Detection Rates when using the Endocuff Enhanced Colonoscopy.
Description
Comparing Polyp Detection Rate when using the Endocuff Enhanced Colonoscopy to retrospective conventional colonoscopy.
Time Frame
1 hour
Title
Number of participants endorsing a comfortable procedure when using the Endocuff assisted colonoscopy assessed by Numerical Rating Scale (NRS).
Description
Results of Numerical Rating Scale pain score when evaluating the rectum with the Endocuff.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Any patient undergoing a colonoscopy during the study period Procedure being performed by a gastroenterologist (i.e., surgeons are excluded) Exclusion Criteria: Inflammatory Bowel Disease Hereditary Mixed Polyposis Syndrome Diverticulitis Colonic stricture Toxic Megacolon Previous Colon surgery, excluding appendectomy Radiation therapy to abdomen or pelvis Pregnancy/Lactation Anticoagulant use Suffered stroke or ischemia in previous 3 months Being deemed too risky by investigator FIT positive Poor preparation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine-Nadia Compas, CRC
Phone
613-746-4621
Ext
3623
Email
christinencompas@montfort.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Dupuis, Med Student
Phone
613-761-0314
Email
oliviadupuis@montfort.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Hassard, MD
Organizational Affiliation
Hopital Montfort
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine-Nadia Compas, CRC
Organizational Affiliation
Hopital Montfort
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Montfort
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1K 0T2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Compas, CRC
Phone
613-746-4621
Ext
3623
Email
christinecompas@montfort.on.ca
First Name & Middle Initial & Last Name & Degree
Mélodie Potvin, CRC
Phone
613-746-4621
Ext
6092
Email
melodiepotvin@montfort.on.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary

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