Status:
TERMINATED
Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus
Lead Sponsor:
University of Michigan
Conditions:
Barrett Esophagus
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
The overall aim of this feasibility study is to develop new technologies for improved detection of Barrett's neoplasia using the scanning fiber endoscope (SFE) imaging system. This study will combine ...
Eligibility Criteria
Inclusion
- Has known or suspected Barrett's esophagus
- Scheduled for a clinically-indicated, upper endoscopy
- Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
- Age 18 to 100 years
- Willing and able to sign informed consent
Exclusion
- Subjects with known allergy or negative reaction to the near infrared fluorophore IRDye800CW, or derivatives
- Subjects on active chemotherapy or radiation treatment
- Pregnant or trying to conceive
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03852576
Start Date
May 9 2019
End Date
November 18 2020
Last Update
November 22 2022
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109