NCT05275556

Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,410 (actual)
• Sponsor: Verily Life Sciences LLC · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colon Adenoma
• Colon Polyp
• Colon Lesion

Interventions

Type	Name	Description
DEVICE	Computer-Assisted Detection (CADe) Device	The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2022-03-11
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

7 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study