Clinical Trial

Digma System First in Human (FIH) Study

Not Yet Recruiting
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Summary
Prospective, open-label, single-arm, early feasibility study (EFS) in 2 Patient cohorts: Cohort A - Dose finding / Dose response study in patients with various etiologies undergoing Esophagectomy and Cohort B - Patients with Barrett's Esophagus (BE) with Low-Grade Dysplasia (LDG) or High-Grade Dysplasia (HGD) without a visible (excisable) lesion. This is a pilot study which plan to enroll up to 5 eligible patients in the First Cohort (A) and up to 15 patients in the Second Cohort (B) of the study.
Trial Details
NCT Number NCT07331857
Lead Sponsor Digma Medical Ltd.
Conditions Barrett's Esophagus (BE)
Enrollment 20 participants
Start Date 2026-01-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-12