Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
Recruiting
Phase 2
Interventional Study
Suspected or Known Squamous Cell Neoplasia
Prior History of Squamous Cell Dysplasia and /or Neoplasia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 200 (estimated)
- Sponsor
- Baylor College of Medicine · Other
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment, including patients with a known history of head/neck squamous cell cancer; heavy smoking and alcohol, other dietary or geographic r…
Contacts