Barrett's Esophagus (BE)NCT07331857
Digma System First in Human (FIH) Study
A study testing Endoscopic Gastrointestinal Ablation Device (EGAD) in people with Barrett's Esophagus (BE), run by Digma Medical Ltd. at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Barrett's Esophagus (BE)
- What is being tested?
- Endoscopic Gastrointestinal Ablation Device (EGAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 25 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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:
- Severe medical comorbidities that preclude endoscopy or multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation .
- Previous radiotherapy in the chest.
- Previous Endoscopic Mucosal resection (EMR) / Endoscopic Submucosal Dissection (ESD) in the esophagus.
- 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).
- Presence of esophageal stricture preventing passage of the endoscope or investigational catheter .
- Active esophagitis.
- Esophageal or gastric varices.
- Subject diagnosed with portal hypertension.
- Subject diagnosed with Liver cirrhosis.
- Presence of severe bleeding or severe inflammation in the area-of-interest.
- Use of anticoagulants or antiplatelet agents that cannot be discontinued 5 days prior to the procedure
- Active systemic infection or malignancy.
- History of esophagectomy
- History of locally advanced (>T1a) esophageal cancer treated endoscopically/by chemoradiotherapy.
- Subjects with known coagulation conditions (e.g. uncontrolled coagulopathy)
- Concurrent chemotherapy.
- 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 CIP .
- Patient refusal or inability to provide written informed consent.
- 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.
- Concurrent enrollment in an investigational drug or device trial that clinically interferes with study endpoints.
- Subject that is unwilling or unable to comply with study visits and other study procedures as required per protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení
Brno, 60200
Jan Martínek, +420 543 182 420, jan.martinek@fnusa.cz
Lucie Jelínková, +420 735 190 319, lucie.jelinkova@fnusa.cz
About this study
Official title: First-in-Human Pilot Study for the Evaluation of Digma Medical's Endoscopic Gastrointestinal Ablation Device (EGAD) in the Esophagus
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.
Read the detailed description
Study intervention means tha application of different doses of laser energy in the ablation of esophageal mucosa using the Digma System and the Endoscopic Gastrointestinal Ablation Device (EGAD) procedure (Cohort A) followed by application of the optimal dose for treatment of patients with BE with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HDG) without a visible lesion (Cohort B).
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
- Barrett's Esophagus (BE)
- Being tested
- Endoscopic Gastrointestinal Ablation Device (EGAD)
- Keywords
- endoscopic gastrointestinal ablation device (EGAD), Barrett's esophagus (BE), esophagus, Digma V2 System, First-in-human pilot study
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Endoscopic Gastrointestinal Ablation Device (EGAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 10-12 months follow-up, at each follow-up visit
Secondary outcomes (10)
Adverse events related to the procedure (Cohort A+B)
Incidence of any adverse events related to the procedure.
Measured: Day 1
Maximal ablation depth (cohort A)
Evaluation of maximum ablation depth. Grading of histology to be conducted in accordance with accepted histological score grading such as depicted in van Munster SM et al. Endoscopy 2021,53,1162-1168 wherein thermal injury was semi-quantitatively scored and the proportion of tissue injury was calculated (depth of thermal changes / total tissue thickness).
Measured: Day 1, ESOPHAGECTOMY surgery
Maximal ablation volume (cohort A)
Evaluation of maximum ablation volume. Following esophagectomy, all resected ablated tissue will be submitted for histopathologic analysis. Analysis of the EGAD treatment ablation sites for evaluation of the ablation outcomes (such as extent of mucosal ablation and depth of penetration) will be conducted per a predefined histological protocol and criterium.
Measured: Day 1, ESOPHAGECTOMY surgery
Dose response effect of treatment(s) on depth-of-penetration. (cohort A)
Evaluation of the dose-dependent effect of treatment on penetration depth, examining how different intensities or doses of the therapy used affect the extent to which the treatment penetrates the tissue, in order to assess the relationship between dose, efficacy, and the potential risks of excessive treatment. Grading of histology to be conducted in accordance with accepted histological score grading such as depicted in van Munster SM et al. Endoscopy 2021,53,1162-1168 wherein thermal injury was semi-quantitatively scored and the proportion of tissue injury was calculated (depth of thermal changes / total tissue thickness).
Measured: Day 1, ESOPHAGECTOMY surgery
Assessment of collateral impact as assessed by histopathologic evaluation.
Assessment of secondary effects, in which histopathological examination is used to assess the extent of undesirable changes in tissues outside the target area in order to determine whether the procedure has caused damage to surrounding structures or other unforeseen tissue reactions.
Measured: 10-12 months follow-up or when eradication of BE is achieved
Rate of complete eradication of dysplasia (cohort B)
The degree of complete eradication of dysplasia, which assesses the extent to which all dysplastic changes in the mucosa have been completely removed or replaced by normal epithelium after treatment, in order to evaluate the overall effectiveness of the therapy and minimize the risk of persistent or recurrent precancerous lesions.
Measured: 10-12 months follow-up
Rate of eradication of intestinal metaplasia. (cohort B)
The degree of eradication of intestinal metaplasia, which monitors how much of the pathologically altered mucosa has been successfully removed or replaced by normal epithelium after treatment in order to assess the effectiveness of therapy and the likelihood of long-term remission.
Measured: 10-12 months follow-up
Eradication of macroscopically visible segment of BE.
Eradication of macroscopically visible Barrett's esophagus, in which complete removal of all clearly altered mucosal areas is assessed to ensure that the pathological epithelium has been treated in its entirety and that no residual focal changes remain.
Measured: 10-12 months follow-up
Assessments of lesion ablation - safe margin area.
Evaluation of lesion ablation, focusing primarily on the size and consistency of the safety margin to ensure that the treated area sufficiently exceeds the boundaries of the lesion and minimizes the risk of incomplete removal.
Measured: 10-12 months follow-up
Assessment of technical aspects of the procedure-time
Evaluation of the technical time of the procedure (minutes or hours), assessing in particular the time required.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start25 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's Esophagus (BE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label, single-arm, early feasibility study (EFS) in 2 Patient cohorts.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Digma Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomit Chappel-Ram, BSc,PhD, Study director, Digma Medical General Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331857
- Sponsor's protocol ID
- CLD-014-BE
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information concerning this study that was not previously published is considered confidential information. This confidential information shall remain the sole property of Digma Medical Ltd.; it shall not be disclosed to others without written consent of Digma Medical Ltd. and shall not be used except in the performance of this study (see also Clinical Trial Agreement). Any investigator involved with this study is obligated to provide the Sponsor with complete test results and all data derived from the study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Pilot Study for the Evaluation of Digma Medical's Endoscopic Gastrointestinal Ablation Device (EGAD) in the Esophagus
- ClinicalTrials.gov ID
- NCT07331857
- Acronym / sponsor ID
- CLD-014-BE
- Conditions
- Barrett's Esophagus (BE)
- Keywords
- endoscopic gastrointestinal ablation device (EGAD), Barrett's esophagus (BE), esophagus, Digma V2 System, First-in-human pilot study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Digma Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study intervention means tha application of different doses of laser energy in the ablation of esophageal mucosa using the Digma System and the Endoscopic Gastrointestinal Ablation Device (EGAD) procedure (Cohort A) followed by application of the optimal dose for treatment of patients with BE with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HDG) without a visible lesion (Cohort B).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label, single-arm, early feasibility study (EFS) in 2 Patient cohorts.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Gastrointestinal Ablation Device (EGAD) | Experimental | 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (37 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Endoscopic Gastrointestinal Ablation Device (EGAD) |
Primary outcome
Cohort A: Incidence of severe immediate adverse events (AEs)
Time frame: Day 1, ESOPHAGECTOMY surgery
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).
Cohort B: Incidence of immediate severe AE
Time frame: Day 1
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).
Cohort B: Incidence of late severe AE
Time frame: 10-12 months follow-up, following each visit and procedure
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.
Cohort A: Dose response effects of ablation on mucosal tissue
Time frame: Day 1, ESOPHAGECTOMY surgery
Cohort A: Dose response effects of ablation on mucosal tissue (assessed by histopathological assessment of mucosal eradication (coagulation necrosis).
Cohort B: Eradication of dysplasia level and of visible segment of BE
Time frame: 10-12 months follow-up, at each follow-up visit
Cohort B: Eradication of dysplasia level and of visible segment of BE assessed macroscopically.
10 secondary outcomes
Adverse events related to the procedure (Cohort A+B)
Time frame: Day 1
Maximal ablation depth (cohort A)
Time frame: Day 1, ESOPHAGECTOMY surgery
Maximal ablation volume (cohort A)
Time frame: Day 1, ESOPHAGECTOMY surgery
Dose response effect of treatment(s) on depth-of-penetration. (cohort A)
Time frame: Day 1, ESOPHAGECTOMY surgery
Assessment of collateral impact as assessed by histopathologic evaluation.
Time frame: 10-12 months follow-up or when eradication of BE is achieved
Rate of complete eradication of dysplasia (cohort B)
Time frame: 10-12 months follow-up
Rate of eradication of intestinal metaplasia. (cohort B)
Time frame: 10-12 months follow-up
Eradication of macroscopically visible segment of BE.
Time frame: 10-12 months follow-up
Assessments of lesion ablation - safe margin area.
Time frame: 10-12 months follow-up
Assessment of technical aspects of the procedure-time
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No. All information concerning this study that was not previously published is considered confidential information. This confidential information shall remain the sole property of Digma Medical Ltd.; it shall not be disclosed to others without written consent of Digma Medical Ltd. and shall not be used except in the performance of this study (see also Clinical Trial Agreement). Any investigator involved with this study is obligated to provide the Sponsor with complete test results and all data derived from the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shlomit Chappel-Ram, BSc,PhD study director
Digma Medical General Manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Gastrointestinal Ablation Device (EGAD) in people with Barrett's Esophagus (BE), run by Digma Medical Ltd. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shlomit Chappel-Ram, BSc,PhD (+972544644518, shlomitc@digmamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A: Incidence of severe immediate adverse events (AEs) (time frame: Day 1, ESOPHAGECTOMY surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.