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NCT05179837 · ClinicalTrials.gov registry record · NA
Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps
A NA study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT05179837: Clinical Trial NA study, sponsored by Washington University School of Medicine.
NCT05179837 is a NA study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05179837, a NA study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
Colorectal cancer arises from the mucosal layer of the colon. Current screening is performed by flexible endoscopy, which involves visual inspection of the mucosal lining of the colon and rectum with an optical camera mounted on the endoscope, with abnormal areas being biopsied. This method is somewhat limited in that there are no readily available surface pattern or morphological classification systems with adequate sensitivity or specificity to evaluate extent of submucosal invasion (deep, superficial, or none). Optical coherence tomography (OCT) using pattern recognition is a high-resolution imaging modality. There is currently an unmet need to predict depth of invasion for colonic tumors to decide on applicability of endoscopic (endoscopic submucosal dissection or endoscopic mucosal resection) vs. surgical therapy. The investigators' hypothesis is that OCT will have a higher diagnostic accuracy for determining depth of submucosal invasion compared to existing modalities. The investigators will first aim to assess the procedural feasibility and safety of using an OCT probe during routine colonoscopy with an early feasibility study. This study will identify appropriate modifications to the device and help with development of subsequent clinical study protocols. The eventual goal is to assess the diagnostic accuracy of OCT imaging for predicting depth of invasion of colonic tumors.
Primary Outcome
If the proportion of the patients whose procedure length using an OCT probe during routine colonoscopy is within 5 minutes is greater than 75%, then the feasibility is defined in this study.
Interventions
- DEVICE Optical coherence tomography probe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2023-04-22 |
| Phase | NA |
Why NCT05179837 stopped before completion
NCT05179837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Optical coherence tomography probe is the first listed.
NCT05179837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05179837 about?
NCT05179837 is a clinical study titled "Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps". Colorectal cancer arises from the mucosal layer of the colon. Current screening is performed by flexible endoscopy, which involves visual inspection of the mucosal lining of the colon and rectum with an optical camera mounted on the endoscope, with abnormal areas being biopsied. This method is somew...
What is the current status of trial NCT05179837?
This trial is currently terminated. It is a NA study. The enrollment target is 36 participants. The study started on 2022-01-24. Estimated completion is 2023-04-22.
What interventions are being tested in trial NCT05179837?
The interventions under investigation include: Optical coherence tomography probe (DEVICE).
Who is sponsoring clinical trial NCT05179837?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05179837's enrollment target sits among peer trials
36 1541st of 2000 higher than 437 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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