Clinical trial NCT05275556: Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Official title: Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Adenoma
Colon Polyp
Colon Lesion
Lead sponsor: Verily Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 1410
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. The control arm is colonoscopy performed with High Definition White Light Endoscopy (HD-WLE) per standard of care. The intervention arm is colonoscopy performed with HD-WLE per standard of care plus the Computer-Assisted Detection (CADe) Device.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥3 years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
* Between the ages of 45 and 80 years, inclusive
* Able and willing to provide written informed consent

Exclusion Criteria:

* Self-reported pregnancy
* Known diagnosis of Colorectal Cancer
* History of, or referral for, Inflammatory Bowel Disease
* Previous surgery involving the colon or rectum
* Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
* High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.
* Referral for overt, symptomatic gastrointestinal bleeding

Primary outcomes:
measure: Difference in Adenomas Per Colonoscopy (APC)
timeFrame: Day 1
measure: Difference in Positive Percent Agreement (PPA)
timeFrame: Day 1
Secondary outcomes:
measure: Adenoma Detection Rate (ADR)
timeFrame: Day 1
measure: Number of False Alerts Per Procedure
timeFrame: Day 1
measure: Mean Withdrawal and Inspection Time (MWT)
timeFrame: Day 1
measure: Polyp Detection Rate (PDR)
timeFrame: Day 1
measure: Proximal Adenoma Detection Rate (pADR)
timeFrame: Day 1
measure: Flat Adenoma Detection Rate (fADR)
timeFrame: Day 1
measure: Serrated Lesions Per Colonoscopy (SLPC)
timeFrame: Day 1
measure: Serrated Lesions Detection Rate (SLDR)
timeFrame: Day 1
measure: Adenoma Detection Rate Including Carcinoma (ADR*)
timeFrame: Day 1
measure: Small Adenoma Detection Rate (sADR)
timeFrame: Day 1
measure: Polyps Per Colonoscopy (PPC)
timeFrame: Day 1
measure: Advanced Adenoma Detection Rate (aADR)
timeFrame: Day 1
measure: False Positive Rate (FPR)
timeFrame: Day 1
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Durham
country: United States
facility: Duke Health
state: North Carolina
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research
state: Ohio
city: Camp Hill
country: United States
facility: Susquehanna Research Group
state: Pennsylvania
city: El Paso
country: United States
facility: ANRC Research
state: Texas
city: Haifa
country: Israel
facility: Elisha Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center (Ichilov)
Study officials:
affiliation: Verily Life Sciences LLC
name: Scooter Plowman, MD
role: STUDY_DIRECTOR
References: