Clinical trial · Interventional
High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia
High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: A Randomized, Multicenter Trial of Accuracy, Yield, and Clinical Impact
- 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 overall objective of this multicenter trial is to determine whether the use of a low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (\< $3, 500) microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at RICE University and provides \>1000X magnified images of the esophageal mucosa.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proflavine, high resolution imaging | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Proflavine, high resolution imaging
- description
- 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.
- interventionNames
- Drug: Proflavine, high resolution imaging
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- No invention
Primary outcomes (1)
- measure
- Comparison of the efficiency of HRME+Lugol's chromoendoscopy (HRME+LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia.
- timeFrame
- 1 day
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All inclusive outpatients undergoing routine (standard of care) Lugol's chromoendoscopic evaluation for suspected or known squamous cell neoplasia will be enrolled as well as any outgoing patients referred to the clinic with any prior history of squamous cell dysplasia and/or neoplasia will also be considered eligible as they will serve as study population for the surveillance group. 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; PTT greater than 50 sec, or INR greater than 2.0 * inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues
References
Publications (1)
- DERIVEDTan MC, Li Z, Patel KK, Zhang F, Yu X, Wang X, Rosen DG, Dawsey SM, Xue L, Hur C, Schwarz RA, Vohra I, Tang Y, Wu M, Wang T, Carns J, Xu H, Richards-Kortum RR, Wang G, Anandasabapathy S. A High-Resolution Microendoscope Improves Esophageal Cancer Screening and Surveillance: Implications for Underserved Global Settings Based on an International Randomized Controlled Trial. Gastroenterology. 2025 Mar;168(3):496-507.e3. doi: 10.1053/j.gastro.2024.10.025. Epub 2024 Oct 29. PMID 39477026