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

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

NCT ID: NCT06116864

Condition: Colon Cancer Screening
Colon Cancer Surveillance

Conditions: Official terms:
Colonic Neoplasms

Conditions: Keywords:
Colon cancer screening
Colon cancer surveillance
Computer-Aided Detection of adenoma
Colonoscope attachment device
Endocuff

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: This is a randomized controlled trial that compares Endocuff with Gi Genius (group A) to GI Genius alone (group B) for patients who are undergoing elective outpatient colonoscopy. Patients will be randomized by a secure online randomization software that will allocate patients in a 1:1 ratio to group A or group B.

Primary purpose: Screening

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Endocuff and GI Genius
Description: Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps
Arm group label: Endocuff + GI Genius

Intervention type: Device
Intervention name: GI Genius
Description: GI Genius is and Computer-Aid Detection (CADe) system to detect polyps
Arm group label: GI Genius

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Marshall University Joan C. Edwards School of Medicine/Cabell Huntington Hospital

Address:
City: Huntington
Zip: 25701
Country: United States

Start date: October 23, 2023

Completion date: April 15, 2025

Lead sponsor:
Agency: Marshall University
Agency class: Other

Source: Marshall University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06116864