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

Sponsor

Hopital Montfort (Other)

Overall Status

Recruiting

CT.gov ID

NCT05615857

Collaborator

AFP Innovation Fund (Other)

900

Enrollment

Location

Arms

7.3

Anticipated Duration (Months)

124

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Colonic Polyps	Device: Use of Endocuff during colonoscopy	N/A

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?

Study Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Sep 22, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Colonoscopy without Endocuff No Endocuff inserted proximally to colonoscope and use of retroflexion
Experimental: Colonoscopy with Endocuff Endocuff inserted proximally to colonoscope, no use of retroflexion	Device: Use of Endocuff during colonoscopy 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

Arm

Intervention/Treatment

No Intervention: Colonoscopy without Endocuff

No Endocuff inserted proximally to colonoscope and use of retroflexion

Experimental: Colonoscopy with Endocuff

Endocuff inserted proximally to colonoscope, no use of retroflexion

Device: Use of Endocuff during colonoscopy

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

Outcome Measures

Primary Outcome Measures

Increase in Polyp Detection Rates when using the Endocuff Enhanced Colonoscopy. [1 hour]
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). [1 hour]
Results of Numerical Rating Scale pain score when evaluating the rectum with the Endocuff.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Montfort	Ottawa	Ontario	Canada	K1K 0T2

Sponsors and Collaborators

Hopital Montfort
AFP Innovation Fund

Investigators

Principal Investigator: Philip Hassard, MD, Hopital Montfort
Study Director: Christine-Nadia Compas, CRC, Hopital Montfort

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hopital Montfort

ClinicalTrials.gov Identifier:

NCT05615857

Other Study ID Numbers:

22-23-04-002

First Posted:

Nov 14, 2022

Last Update Posted:

Nov 14, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Hopital Montfort

Additional relevant MeSH terms:

Polyps

Colonic Polyps

Study Results

No Results Posted as of Nov 14, 2022