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

NCT05396781 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-06-09

No results posted yet for this 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.

Conditions

  • Suspected or Known Squamous Cell Neoplasia
  • Prior History of Squamous Cell Dysplasia and /or Neoplasia

Interventions

DRUG

Proflavine

5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.

DEVICE

Mobile, Augmented High Resolution Microendoscope

The marHRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.

Sponsors & Collaborators

  • William Marsh Rice University

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • University of Sao Paulo

    collaborator OTHER

  • Anandasabapathy, Sharmila, M.D.

    lead INDIV

Principal Investigators

  • Sharmila Anandasabapathy, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2022-01-20
Completion
2022-01-20
FDA Drug
Yes

Countries

  • United States
  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05396781 on ClinicalTrials.gov