Digma System First in Human (FIH) Study (NCT07331857) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Digma System First in Human (FIH) Study
Czechia20 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or Female ≥18 years of age at the time of consent.
✓. Scheduled to undergo esophagectomy for malignant or benign indications .
✓. Contain enough healthy (or with BE) tissue to be ablated (≥1cm) by for EGAD treatment.
✓. Capable of providing written informed consent.
✓. Male or Female ≥18 and ≤ 70 years of age at the time of consent.
✓. Documented diagnosis of Barrett's Esophagus (BE) with LGD or HGD, confirmed by biopsy specimen analysis.
✓. No visible lesion in the esophagus (suitable for endoscopic resection).
✓. Scheduled to undergo Endoscopic eradication therapy (EET) procedure of Barrett's Esophagus (BE) with dysplasia.
Exclusion criteria
✕. Severe medical comorbidities that preclude esophagectomy.
✕. Any medical or technical condition that may preclude endoscopy during surgical esophagectomy at the discretion of operating surgeon.
✕. Any previous procedures involving esophageal tissue resection or ablation.
✕. Patients with incomplete healing of tissue following radiation at the area-of-interest.
✕
What they're measuring
1
Cohort A: Incidence of severe immediate adverse events (AEs)
Timeframe: Day 1, ESOPHAGECTOMY surgery
2
Cohort B: Incidence of immediate severe AE
Timeframe: Day 1
3
Cohort B: Incidence of late severe AE
Timeframe: 10-12 months follow-up, following each visit and procedure
4
Cohort A: Dose response effects of ablation on mucosal tissue
Timeframe: Day 1, ESOPHAGECTOMY surgery
5
Cohort B: Eradication of dysplasia level and of visible segment of BE
Timeframe: 10-12 months follow-up, at each follow-up visit
. Subjects undergoing (or having undergone) photodynamic therapy.
✕. Subjects of high surgical risk, in which any delay in the esophagectomy surgery may, in the option of the PI, increase the risk for to Adverse event (AE) / Serious Adverse event (SAE).
✕. Presence of esophageal stricture preventing passage of the endoscope or investigational catheter .
✕. Any anatomical abnormality (such as but not limited to, esophageal dilation) that, at the discretion of the investigator may preclude the laser ablation.