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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 is a Early Phase 1 study that was terminated before completion, run by Anandasabapathy, Sharmila, M.D.. The registered enrollment target is 67 participants.

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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

FieldValue
Enrollment Target 67 participants
Start Date 2009-06
Est. Completion 2014-02
Phase Early Phase 1

Sponsor

Anandasabapathy, Sharmila, M.D.

6 total trials

What the Registry Record Tells You About NCT01384695

The ClinicalTrials.gov registry entry for NCT01384695 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anandasabapathy, Sharmila, M.D., which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Proflavine hemisulfate is the first listed.

NCT01384695 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.