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

NCT ID: NCT05615857

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-22
• Study Completion Date: 2023-07-31

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?

Conditions

Colorectal Cancer; Colonic Polyps

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Colonoscopy without Endocuff

No Endocuff inserted proximally to colonoscope and use of retroflexion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Colonoscopy with Endocuff

Endocuff inserted proximally to colonoscope, no use of retroflexion

Group Type: EXPERIMENTAL

Use of Endocuff during colonoscopy

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AFP Innovation Fund

OTHER

Sponsor Role: collaborator

Hopital Montfort

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Hassard, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Montfort

Christine-Nadia Compas, CRC

Role: STUDY_DIRECTOR

Hopital Montfort

Locations

Hopital Montfort

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

22-23-04-002

Identifier Type: -

Identifier Source: org_study_id