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

Marshall University

Status: Invitation-only

Conditions: Colon Cancer Surveillance; Colon Cancer Screening

Treatments: Device: GI Genius; Device: Endocuff and GI Genius

Study type: Interventional

Funder types: Other

Identifiers

NCT06116864

2094805

Details and patient eligibility

About

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.

Enrollment: 1,766 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,766 participants in 2 patient groups

Endocuff + GI Genius

Experimental group

Description:

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

Treatment:

Device: Endocuff and GI Genius

GI Genius

Active Comparator group

Description:

GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Treatment:

Device: GI Genius