Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2026-01-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus
NCT00526786
WATS3D for the Detection of Esophageal Dysplasia
NCT03008980
Trial of a Gastrin Receptor Antagonist in Barrett's Esophagus
NCT01298999
Quality of Life in Barrett's Esophagus and Gastro-Esophageal Reflux Disease
NCT01572974
Minimal Injuries From Esophagus Detected by Optical Enhancement System™ Associated to Optical Magnification HD Scopes
NCT02575287
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
EGAD is a proprietary, controlled laser ablation system for the treatment of endoluminal pathologies of the gastrointestinal tract. EGAD achieves high precision through a unique optical design that controls laser energy, beam size, wavelength, and focal plane. This allows for effective ablation that is limited to the mucosa of pre-selected regions of interest, avoiding a wider and deeper injury to healthy tissue. EGAD procedure can be performed safely in a standard endoscopy suite under direct endoscopic visualization. In this First-in-Human pilot feasibility study, we plan to assess the feasibility of EGAD for achieving mucosal ablation (1) in healthy esophageal tissue in patients undergoing esophagectomy for esophageal cancer or other indications (Barrett's mucosa may be ablated as well) - Cohort A; and (2) In patients with Barrett's Esophagus with low and/or high-grade dysplasia (BORN = Barrett´s Oesophagus-Related Neoplasia) without a visible (excisable) lesion - Cohort B.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Male or Female ≥18 years of age at the time of consent.
2. Scheduled to undergo esophagectomy for malignant or benign indications .
3. Contain enough healthy (or with BE) tissue to be ablated (≥1cm) by for EGAD treatment.
4. Capable of providing written informed consent.
Cohort B:
1. Male or Female ≥18 and ≤ 70 years of age at the time of consent.
2. Documented diagnosis of Barrett's Esophagus (BE) with LGD or HGD, confirmed by biopsy specimen analysis.
3. No visible lesion in the esophagus (suitable for endoscopic resection).
4. Scheduled to undergo Endoscopic eradication therapy (EET) procedure of Barrett's Esophagus (BE) with dysplasia.
5. BE affected tissue length ≥1 cm and ≤ 5cm (as measured endoscopically).
6. Capable of providing written informed consent.
7. Willingness and ability to comply with follow-up requirements, including endoscopies and biopsies.
8. Ability to tolerate and take oral proton pump inhibitor (PPI) medication.
Exclusion Criteria
1. Severe medical comorbidities that preclude esophagectomy.
2. Any medical or technical condition that may preclude endoscopy during surgical esophagectomy at the discretion of operating surgeon.
3. Any previous procedures involving esophageal tissue resection or ablation.
4. Patients with incomplete healing of tissue following radiation at the area-of-interest.
5. Subjects undergoing (or having undergone) photodynamic therapy.
6. 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).
7. Presence of esophageal stricture preventing passage of the endoscope or investigational catheter .
8. Any anatomical abnormality (such as but not limited to, esophageal dilation) that, at the discretion of the investigator may preclude the laser ablation.
9. Presence of esophageal varices in the esophagus.
10. Presence of severe bleeding or severe inflammation at the time of endoscopy of EGAD.
11. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method .
12. Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the Clinical Investigation Plan (CIP).
13. Patient refusal or inability to provide written informed consent.
Cohort B:
1. Severe medical comorbidities that preclude endoscopy or multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation .
2. Previous radiotherapy in the chest.
3. Previous Endoscopic Mucosal resection (EMR) / Endoscopic Submucosal Dissection (ESD) in the esophagus.
4. Subjects currently undergoing or subject that had previous ablative therapy within the esophagus (e.g., Photodynamic Therapy (PDT), Multipolar Electrocoagulation (MPEC), Argon Plasma Coagulation (APC), laser treatment, radiofrequency ablation (RFA).
5. Presence of esophageal stricture preventing passage of the endoscope or investigational catheter .
6. Active esophagitis.
7. Esophageal or gastric varices.
8. Subject diagnosed with portal hypertension.
9. Subject diagnosed with Liver cirrhosis.
10. Presence of severe bleeding or severe inflammation in the area-of-interest.
11. Use of anticoagulants or antiplatelet agents that cannot be discontinued 5 days prior to the procedure
12. Active systemic infection or malignancy.
13. History of esophagectomy
14. History of locally advanced (\>T1a) esophageal cancer treated endoscopically/by chemoradiotherapy.
15. Subjects with known coagulation conditions (e.g. uncontrolled coagulopathy)
16. Concurrent chemotherapy.
17. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
18. Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the CIP .
19. Patient refusal or inability to provide written informed consent.
20. Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions, uncontrolled psychiatric illness (including recent inpatient psychiatric treatment, psychosis, moderate to severe depression, illicit substance abuse) or any psychiatric diagnosis which in the opinion of the investor would preclude participation in the study.
21. Concurrent enrollment in an investigational drug or device trial that clinically interferes with study endpoints.
22. Subject that is unwilling or unable to comply with study visits and other study procedures as required per protocol.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Digma Medical Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shlomit Chappel-Ram, BSc,PhD
Role: STUDY_DIRECTOR
Digma Medical General Manager
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení
Brno, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLD-014-BE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.