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NCT05396781 · ClinicalTrials.gov registry record · Phase 2

Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening

A Phase 2 study, sponsored by Anandasabapathy, Sharmila, M.D..

Completed
Registry status
Phase 2
Development phase
41
Enrollment target

NCT05396781: Completed Phase 2 study, sponsored by Anandasabapathy, Sharmila, M.D..

NCT05396781 is a Phase 2 study that has completed, run by Anandasabapathy, Sharmila, M.D.. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05396781, a Phase 2 study, has completed, sponsored by Anandasabapathy, Sharmila, M.D..

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target

Study Summary

The investigators have a current trial in China and the US which provides significant support for the safety, cost-effectiveness, accuracy and efficiency of a high resolution microendoscope (HRME)-guided approach in the hands of experienced clinicians. To improve functionality, portability and broader use of this device by non-experts, the investigators recently developed a prototype marHRME platform with an automated, augmented reality (AR)-interpretation that provides an overlaid endoscopic + micro-endoscopic view, facilitating diagnosis and biopsy targeting.

Primary Outcome

The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies.

Interventions

  • DRUG Proflavine
  • DEVICE Mobile, Augmented High Resolution Microendoscope

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2022-01-13
Est. Completion 2022-01-20
Phase Phase 2
Anandasabapathy, Sharmila, M.D.

6 total trials

What the finished NCT05396781 record still lists

NCT05396781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).

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

NCT05396781 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05396781 about?

NCT05396781 is a clinical study titled "Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening". The investigators have a current trial in China and the US which provides significant support for the safety, cost-effectiveness, accuracy and efficiency of a high resolution microendoscope (HRME)-guided approach in the hands of experienced clinicians. To improve functionality, portability and broad...

What is the current status of trial NCT05396781?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2022-01-13. Estimated completion is 2022-01-20.

What interventions are being tested in trial NCT05396781?

The interventions under investigation include: Proflavine (DRUG), Mobile, Augmented High Resolution Microendoscope (DEVICE).

Who is sponsoring clinical trial NCT05396781?

This trial is sponsored by Anandasabapathy, Sharmila, M.D., which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05396781's enrollment target sits among peer trials

41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT05396781, the US trial registry maintained by the National Library of Medicine. NCT05396781 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.