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NCT03925337 · ClinicalTrials.gov registry record · NA
Computer Aided Detection of Polyps in the Colon
A NA study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 234
- Enrollment target
NCT03925337: Completed NA study, sponsored by Beth Israel Deaconess Medical Center.
NCT03925337 is a NA study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 234 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03925337, a NA study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 234 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the role of an automatic polyp detection software (henceforth referred to as the research software) as a support system during colonoscopy; a procedure during which a physician uses a colonoscope or scope, to look inside a patient's rectum and colon. The scope is a flexible tube with a camera-to see the lining of the colon. The research software is used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. The research software used in this study was programmed by a company in Shanghai, which develops artificial intelligence software for computer aided diagnostics. The research software was developed using a large repository (database or databases) of polyp images where expert colonoscopists outlined polyps and suspicious lesions. The software was subsequently developed and validated using several databases of images and video to operate in near real-time or within minutes of photographing the tissue. It is intended to point out polyps and suspicious lesions on a separate screen that stands behind the primary monitor during colonoscopy. It is not expected to change the colonoscopy procedure in any way, and the physician will make the final determination on whether or not to biopsy or remove any lesion in the colon wall. The research software will not record any video data during the colonoscopy procedure. In the future, this software may help gastroenterologists detect precancerous areas and decrease the incidence of colon cancer in the United States.
Primary Outcome
Adenoma Miss Rate (AMR), to determine if the combination technique identifies more adenomas compared to the standard technique. AMR will be calculated as the number of adenomas detected on the second pass or portion in either group divided by the total number of adenomas detected during both passes
Interventions
- DEVICE Computer Aided Diagnostic Software
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2019-05-07 |
| Est. Completion | 2021-05-12 |
| Phase | NA |
What the finished NCT03925337 record still lists
NCT03925337 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Computer Aided Diagnostic Software is the first listed.
NCT03925337 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03925337 about?
NCT03925337 is a clinical study titled "Computer Aided Detection of Polyps in the Colon". The purpose of this study is to examine the role of an automatic polyp detection software (henceforth referred to as the research software) as a support system during colonoscopy; a procedure during which a physician uses a colonoscope or scope, to look inside a patient's rectum and colon. The scope...
What is the current status of trial NCT03925337?
This trial is currently completed. It is a NA study. The enrollment target is 234 participants. The study started on 2019-05-07. Estimated completion is 2021-05-12.
What interventions are being tested in trial NCT03925337?
The interventions under investigation include: Computer Aided Diagnostic Software (DEVICE).
Who is sponsoring clinical trial NCT03925337?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03925337's enrollment target sits among peer trials
234 462nd of 2000 higher than 1,538 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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