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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.