Clinical trial · Interventional
Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening
Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening: A Clinical Study in Brazil
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prior History of Squamous Cell Dysplasia and /or Neoplasia | — | UNRESOLVED | — |
| Suspected or Known Squamous Cell Neoplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mobile, Augmented High Resolution Microendoscope | Device | — | UNRESOLVED |
| Proflavine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Augmented Reality High Resolution Microendoscope (HRME) imaging
- description
- All study subjects will receive White Light Imaging and Lugol's Chromoendoscopy (LCE) which is the current standard of care procedure. The investigators will record any LCE abnormal areas and record the clinician's plan of action. Following LCE, all subjects will receive Mobile, Augmented Reality High Resolution Microendoscope (marHRME) imaging with the study contrast agent (Proflavine) of any LCE-identified abnormal areas as well as LCE normal areas. The investigators will record the subjective clinician read and confidence level in the investigators' diagnosis, and plan of action. Then the investigators will image the same abnormal and normal areas with the marHRME and record the software read, clinician confidence level, and plan of action. Finally, the imaged areas will be biopsied or resected and evaluated by a pathologist. All subjects will receive both standard of care and marHRME imaging.
- interventionNames
- Drug: Proflavine
- Device: Mobile, Augmented High Resolution Microendoscope
Primary outcomes (3)
- measure
- Diagnostic yield
- timeFrame
- Day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment including patients with known history of head/neck squamous cell cancer. * Patients must be \>18 years old and able to give informed consent. * For the provider surveys and interviews, all providers (clinicians, trainees) who are working on the project will be eligible to participate. Exclusion Criteria: * Allergy or prior reaction to the fluorescent contrast agent proflavine * Patients who are unable to give informed consent * Known advanced squamous cell carcinoma of the distal esophagus, or dyplastic/suspected malignant esophageal lesion greater than or equal to 2cm in size not amenable to endoscopic therapy * Patient unable to undergo routine endoscopy with biopsy * Women who are pregnant or breastfeeding * Prothrombin time greater than 50% of control; Partial Thromboplastin Time greater than 50 sec, or International Normalized Ratio greater than 2.0 * inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues * Providers will be excluded if they decline participation or otherwise opt out of the proposed research project.
References
Publications (0)
Data not yet available