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

NCT05615857 | Completed FDA Device

• 1 other identifier: 22-23-04-002
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colonic Polyps

Keywords

Endocuff; Retroflexion; Colonoscopy; Polyp detection; Screening

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Colonoscopy without Endocuff

NO INTERVENTION

No Endocuff inserted proximally to colonoscope and use of retroflexion

Colonoscopy with Endocuff

EXPERIMENTAL

Endocuff inserted proximally to colonoscope, no use of retroflexion

Device: Use of Endocuff during colonoscopy

Interventions

Use of Endocuff during colonoscopy 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

Colonoscopy with Endocuff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient undergoing a colonoscopy during the study period
• Procedure being performed by a gastroenterologist (i.e., surgeons are excluded)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Montfort: lead
• AFP Innovation Fund: collaborator

Study Sites (1)

Hopital Montfort

Ottawa, Ontario, K1K 0T2, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip Hassard, MD

  Hopital Montfort

  PRINCIPAL INVESTIGATOR

• Christine-Nadia Compas, CRC

  Hopital Montfort

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: November 14, 2022
• Study Start: September 22, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)