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NOT YET RECRUITING
NCT07331857
NA

Digma System First in Human (FIH) Study

Sponsor: Digma Medical Ltd.

View on ClinicalTrials.gov

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.

Official title: First-in-Human Pilot Study for the Evaluation of Digma Medical's Endoscopic Gastrointestinal Ablation Device (EGAD) in the Esophagus

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-01-01

Completion Date

2027-12-31

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DEVICE

Endoscopic Gastrointestinal Ablation Device (EGAD)

Application of different doses of laser energy in the ablation of esophageal mucosa using the Digma System and the EGAD procedure (Cohort A) followed by application of the optimal dose for treatment of patients with BE with LGD or HDG without a visible lesion (Cohort B).

Locations (1)

Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení

Brno, Czechia