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

Not Applicable

• Conditions: Colon Cancer Screening; Colon Cancer Surveillance
• Interventions: Device: Endocuff and GI Genius; Device: GI Genius

• Registration Number: NCT06116864
• Lead Sponsor: Marshall University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-23
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1766

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endocuff + GI Genius	Endocuff and GI Genius	Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps
GI Genius	GI Genius	GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	18 months	It is the percentage of patients who have at least one adenoma detected during the colonoscopy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Marshall University Joan C. Edwards School of Medicine/Cabell Huntington Hospital; 🇺🇸 Huntington, West Virginia, United States