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NCT01384695 · ClinicalTrials.gov registry record · Early Phase 1
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
A Early Phase 1 study, sponsored by Anandasabapathy, Sharmila, M.D..
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 67
- Enrollment target
NCT01384695: Clinical Trial Early Phase 1 study, sponsored by Anandasabapathy, Sharmila, M.D..
NCT01384695 is a Early Phase 1 study that was terminated before completion, run by Anandasabapathy, Sharmila, M.D.. The registered enrollment target is 67 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01384695, a Early Phase 1 study, was terminated before completion, sponsored by Anandasabapathy, Sharmila, M.D..
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.
Interventions
- DRUG Proflavine hemisulfate
- DRUG Fluorescein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2009-06 |
| Est. Completion | 2014-02 |
| Phase | Early Phase 1 |
Why NCT01384695 stopped before completion
NCT01384695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 2 interventions - of which Proflavine hemisulfate is the first listed.
NCT01384695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01384695 about?
NCT01384695 is a clinical study titled "A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1". The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of usi...
What is the current status of trial NCT01384695?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 67 participants. The study started on 2009-06. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01384695?
The interventions under investigation include: Proflavine hemisulfate (DRUG), Fluorescein (DRUG).
Who is sponsoring clinical trial NCT01384695?
This trial is sponsored by Anandasabapathy, Sharmila, M.D., which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01384695's enrollment target sits among peer trials
67 362nd of 2000 higher than 1,638 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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