Status:
COMPLETED
Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening
Lead Sponsor:
Anandasabapathy, Sharmila, M.D.
Collaborating Sponsors:
William Marsh Rice University
Baylor College of Medicine
Conditions:
Suspected or Known Squamous Cell Neoplasia
Prior History of Squamous Cell Dysplasia and /or Neoplasia
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief 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)-gui...
Detailed Description
The investigators' hypothesis is that this mobile device with automated, AR optical biopsy diagnoses can efficiently and accurately facilitate endoscopic cancer detection in low to middle income count...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05396781
Start Date
January 13 2022
End Date
January 20 2022
Last Update
June 9 2022
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
University of Sao Paulo
São Paulo, São Paulo, Brazil, 01246-000