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

Study Overview
=================
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.

Official Title
-----------------
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.

Conditions
-----------------
Colon Cancer Screening, Colon Cancer Surveillance

Intervention / Treatment
-----------------
* Device: Endocuff and GI Genius
* Device: GI Genius


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon cancer screening, Colon cancer surveillance, Computer-Aided Detection of adenoma, Colonoscope attachment device, Endocuff