Digma System First in Human (FIH) Study

NCT07331857 | Not Yet Recruiting

• 1 other identifier: CLD-014-BE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Barrett's Esophagus (BE)

Keywords

endoscopic gastrointestinal ablation device (EGAD); Barrett's esophagus (BE); esophagus; Digma V2 System; First-in-human pilot study

Outcome Measures

Primary Outcomes (5)

• Cohort A: Incidence of severe immediate adverse events (AEs)

  Cohort A: Incidence of severe immediate adverse events (AEs) that are directly associated with EGAD procedure (esophageal perforation, bleeding, patient hemodynamic or respiratory decompensation during the procedure or death following the procedure).

  Day 1, ESOPHAGECTOMY surgery

• Cohort B: Incidence of immediate severe AE

  Cohort B: Incidence of immediate severe AE (including esophageal perforation, bleeding, patient hemodynamic or respiratory decompensation during the procedure or death following the procedure, esophageal stricture rate after ablation).

  Day 1

• Cohort B: Incidence of late severe AE

  Cohort B: Incidence of late severe AE (including esophageal perforation, bleeding, patient hemodynamic or respiratory decompensation during the procedure or death following the procedure, esophageal stricture rate after ablation). A dedicated designed Questioner will be used.

  10-12 months follow-up, following each visit and procedure

• Cohort A: Dose response effects of ablation on mucosal tissue

  Cohort A: Dose response effects of ablation on mucosal tissue (assessed by histopathological assessment of mucosal eradication (coagulation necrosis).

  Day 1, ESOPHAGECTOMY surgery

• Cohort B: Eradication of dysplasia level and of visible segment of BE

  Cohort B: Eradication of dysplasia level and of visible segment of BE assessed macroscopically.

  10-12 months follow-up, at each follow-up visit

Secondary Outcomes (10)

• Adverse events related to the procedure (Cohort A+B)

  Day 1

• Maximal ablation depth (cohort A)

  Day 1, ESOPHAGECTOMY surgery

• Maximal ablation volume (cohort A)

  Day 1, ESOPHAGECTOMY surgery

• Dose response effect of treatment(s) on depth-of-penetration. (cohort A)

  Day 1, ESOPHAGECTOMY surgery

• Assessment of collateral impact as assessed by histopathologic evaluation.

  10-12 months follow-up or when eradication of BE is achieved

Study Arms (1)

Endoscopic Gastrointestinal Ablation Device (EGAD)

EXPERIMENTAL

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).

Device: Endoscopic Gastrointestinal Ablation Device (EGAD)

Interventions

Endoscopic Gastrointestinal Ablation Device (EGAD) DEVICE

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).

Endoscopic Gastrointestinal Ablation Device (EGAD)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort A:
• 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.
• Cohort B:
• 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.
• BE affected tissue length ≥1 cm and ≤ 5cm (as measured endoscopically).
• Capable of providing written informed consent.
• Willingness and ability to comply with follow-up requirements, including endoscopies and biopsies.
• Ability to tolerate and take oral proton pump inhibitor (PPI) medication.

You may not qualify if:

• Cohort A:
• 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.
• Presence of esophageal varices in the esophagus.
• Presence of severe bleeding or severe inflammation at the time of endoscopy of EGAD.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method .
• Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the Clinical Investigation Plan (CIP).
• Patient refusal or inability to provide written informed consent.
• Cohort B:

Sponsors & Collaborators

• Digma Medical Ltd.: lead

Study Sites (1)

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

Brno, 60200, Czechia

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Shlomit Chappel-Ram, BSc,PhD

  Digma Medical General Manager

  STUDY DIRECTOR

Central Study Contacts

Shlomit Chappel-Ram, BSc,PhD

CONTACT

+972544644518; shlomitc@digmamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, single-arm, early feasibility study (EFS) in 2 Patient cohorts.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)