To Compare Artificial Intelligence Software Aided Adenoma Detection in Screening Colonoscopies Versus Standard Colonoscopy Without Artificial Intelligence Software Assistance in Participants Between 45 and 75 Years of Age
Public ClinicalTrials.gov record NCT04196088. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
AIDA: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Artificial Intelligence (AI) Detection of Adenomas (AIDA) With Standard High Definition With Light in Screening Colonoscopy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for clinical trial safety assessment. The remainder of subjects who are eligible will enter the detection phase which comprises a screening colonoscopy procedure. In the detection phase, subjects will be randomized to a screening colonoscopy with Ultivision AI Software enhancement or without AI Software enhancement. The study will measure the mean adenomas per colonoscopy procedure, as defined by the protocol, detected while receiving either treatment option.
Study identification
- NCT ID
- NCT04196088
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 978 participants
Conditions and interventions
Interventions
- Ultivision Artificial Intelligence Software Device
- No Artificial Intelligence Software enhancement Device
Device
Eligibility (public fields only)
- Age range
- 45 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 10, 2020
- Primary completion
- Oct 31, 2021
- Completion
- Nov 30, 2021
- Last update posted
- Mar 18, 2021
2020 – 2021
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Gastro Health | Birmingham | Alabama | 35209 | Recruiting |
| Precision Research Institute | San Diego | California | 92114 | Recruiting |
| Kansas City Veterans Administration | Kansas City | Kansas | 66103 | Recruiting |
| Capital Digestive Care | Chevy Chase | Maryland | 20815 | Recruiting |
| East Side Endoscopy | New York | New York | 10010 | Recruiting |
| Great Lakes Gastroenterology Research, LLC, Clinical Trials Network | Mentor | Ohio | 44060 | Recruiting |
| Verity Research Inc., Gastro Health | Fairfax | Virginia | 22031 | Recruiting |
| Gastrointestinal & Liver Specialists of Tidewater, PLLC | Norfolk | Virginia | 23502 | Recruiting |
| Wisconsin GI Associates | Milwaukee | Wisconsin | 53215 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04196088, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 18, 2021 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04196088 live on ClinicalTrials.gov.