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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615857
• Other study ID #: 22-23-04-002
• Status: Completed
• Phase: N/A
• Start date: September 22, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2024
• Source: Hopital Montfort
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyps
• Colorectal Cancer
• Polyps

Intervention

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

Locations

Country	Name	City	State
Canada	Hopital Montfort	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hopital Montfort	AFP Innovation Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour
Primary	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.	1 hour