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Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
NCT06435286 · View on ClinicalTrials.gov ↗
Study Summary
In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) interpretation by experts but not the novice and in the surveillance arm (100% vs. 19%, p \<0.05). In the screening arm, diagnostic yield (neoplastic biopsies/total biopsies) increased 3.6 times (8 to 29%); 16% of patients were correctly spared any biopsy, and 18% had a change in clinical plan. In a pilot study in Brazil, the investigators tested a software-assisted mHRME with deep-learning software algorithms to aid in the detection of neoplastic images and determine the performance, efficiency, and impact of the AI-mHRME when to Lugol's chromoendoscopy (LCE) alone and when using AI-mHRME with LCE. In this clinical trial, the investigators will build on the Brazil pilot trial data to optimize an artificial intelligence (AI) mHRME and evaluate its clinical impact and implementation potential in ethnically and socioeconomically diverse populations in the US and Brazil.
Conditions Studied
Interventions
- DRUG Proflavine Hemisulfate
- DEVICE Artificial Intelligence Mobile High-Resolution Microendoscope
Study Locations (4)
Texas
- Baylor St. Luke's Medical Center — Houston
- Ben Taub Hospital (Harris Health Systems) — Houston
São Paulo
- Hospital de Cancer de Barretos - Fundacao Pio XII — Barretos
- Instituto do Câncer do Estado de São Paulo — São Paulo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-02-17 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06435286
The ClinicalTrials.gov registry entry for NCT06435286 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 678 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Suspected or Known Squamous Cell Neoplasia appearing as the primary indexed condition, and to 2 interventions — of which Proflavine Hemisulfate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06435286 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Texas, São Paulo. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06435286 about?
NCT06435286 is a clinical study titled "Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States". In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) int...
What is the current status of trial NCT06435286?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2025-02-17. Estimated completion is 2027-03-01.
What conditions does trial NCT06435286 study?
This clinical trial studies the following conditions: Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06435286?
The interventions under investigation include: Proflavine Hemisulfate (DRUG), Artificial Intelligence Mobile High-Resolution Microendoscope (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06435286?
This trial is sponsored by Baylor College of Medicine, which has 678 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06435286 being conducted?
This trial has 4 study locations across Texas, São Paulo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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