Enchasing Polyp Detection: The Effect of Adding Polyp Detection Attachment Device to Computer Aid Detection System.

Enhancing Polyp Detection: A Randomized Controlled Trial Comparing Combined Computer-Aid Detection and Polyp-Detecting Colonoscope Attachment to Computer-Aid Detection Alone in Patients Undergoing Colonoscopy.

Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colon Cancer Screening; Colon Cancer Surveillance
• Intervention / Treatment: Device: Endocuff and GI Genius; Device: GI Genius

• Study Type: Interventional
• Enrollment (Estimated): 1766
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall University Joan C. Edwards School of Medicine/Cabell Huntington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age > 18
• Patients scheduled for an outpatient screening or surveillance colonoscopy.

Exclusion Criteria:

• Patients who require diagnostic colonoscopy (e.g.; anemia or GI bleeding).
• Patients requiring deep ileal intubation.
• Patients with inflammatory bowel disease.
• Patients with radiotherapy-induced colitis or other severe colitis.
• Patients with colonic strictures.
• Patients with acute diverticulitis.
• Patients with large bowel obstruction.
• Patients scheduled for therapeutic colonoscopy (e.g., planned endoscopic mucosal resection for known polyps).
• Patients scheduled for assessment of a known colonic lesion.
• Patients with a known history of hereditary polyposis syndrome or untreated colon cancer.
• Patients with a history of colon resection.
• Patients on continuous anti-thrombotic therapy
• Pregnancy.
• Patients who are ineligible for colonoscopy due to medical or psychiatric conditions.
• Patients who are vulnerable or unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endocuff + GI Genius; Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps	Device: Endocuff and GI Genius; Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps
Active Comparator: GI Genius; GI Genius is and Computer-Aid Detection (CADe) system to detect polyps	Device: GI Genius; GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	It is the percentage of patients who have at least one adenoma detected during the colonoscopy	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Polyp detection rate	18 months
Number of cancerous lesions	18 months
Differences in polyps histology between the groups	18 months
Differences in polyps size	18 months
Polyps location (cecum, ascending, transverse, descending, sigmoid, or rectum)	18 months
Cecal intubation rate	18 months
Cecal intubation time	18 months
Colonoscopy withdrawal time	18 months
Procedure complication (bleeding or perforation) by the end of the procedure. (Following lexicon for endoscopic adverse events methods)	18 months

Collaborators and Investigators

• Sponsor: Marshall University
• Investigators: Principal Investigator: Wesam Frandah, MD, Marshall University Joan C. Edwards School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 15, 2025

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Colon cancer screening; Endocuff; Colon cancer surveillance; Computer-Aided Detection of adenoma; Colonoscope attachment device
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 2094805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes