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Computer-Assisted Detection (CADe) Device for Colon Adenomas (GAIN Trial)

N/A
Waitlist Available
Research Sponsored by Verily Life Sciences LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights

GAIN Trial Summary

This trial is testing a new device to see if it helps find adenomas (a type of precancerous growth) during routine colonoscopies.

Eligible Conditions
  • Colon Adenomas
  • Colon Polyps
  • Colon Lesions

GAIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in Adenomas Per Colonoscopy (APC)
Difference in Positive Percent Agreement (PPA)
Secondary outcome measures
Adenoma Detection Rate (ADR)
Adenoma Detection Rate including Carcinoma (ADR*)
Advanced Adenoma Detection Rate (aADR)
+10 more

GAIN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CADe DeviceExperimental Treatment1 Intervention
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Group II: Colonoscopy (Standard of Care)Active Control1 Intervention
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computer-Assisted Detection (CADe) Device
2022
N/A
~1410

Find a Location

Who is running the clinical trial?

Verily Life Sciences LLCLead Sponsor
16 Previous Clinical Trials
23,266 Total Patients Enrolled
Scooter Plowman, MDStudy DirectorVerily Life Sciences LLC
1 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

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