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NCT07331857

Digma System First in Human (FIH) Study

Not yet recruiting NA Last updated 12 January 2026
What this trial tests

NA trial testing Endoscopic Gastrointestinal Ablation Device (EGAD) in Barrett's Esophagus (BE) in 20 participants. Not yet recruiting.

Timeline
1 January 2026
Primary endpoint
31 December 2026
31 December 2027

Quick facts

Lead sponsorDigma Medical Ltd.
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date1 January 2026
Primary completion31 December 2026
Estimated completion31 December 2027
Sites1 location across Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Digma Medical Ltd.

Who can join

Adults 18 to 70, any sex, with Barrett's Esophagus (BE). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Digma Medical Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07331857.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing