Gastroesophageal Reflux Disease (GERD)NCT07344935
Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy
A study testing Ezisurg stapler SLEEVE technique and Ethicon Stapler SLEEVE technique in people with Gastroesophageal Reflux Disease (GERD), run by Ezisurg Medical Co. Ltd. at 1 site in France.
Trial summary
The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique), intends for decrease the rate of gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- Ezisurg stapler SLEEVE technique and Ethicon Stapler SLEEVE technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) ≥ 30 kg/m² (or BMI ≥ 27 kg/m² with at least one obesity-related comorbidity, e.g., type 2 diabetes, hypertension, dyslipidemia).
- Medically eligible for laparoscopic sleeve gastrectomy (LSG) or Nissan sleeve surgery, as determined by a multidisciplinary bariatric team (e.g., surgeon, endocrinologist, dietitian).
- Ability to understand and voluntarily sign written informed consent.
- Willingness to comply with post-operative follow-up protocols (e.g., dietary monitoring, clinical visits, laboratory tests).
Who cannot join
- BMI < 30 kg/m² (or < 27 kg/m² without obesity-related comorbidities).
- Contraindications to laparoscopic surgery (e.g., severe abdominal adhesions, hemodynamic instability, uncorrected coagulopathy).
- History of major gastrointestinal surgery (e.g., gastric bypass, colectomy) or anatomical abnormalities precluding sleeve gastrectomy.
- Active or uncontrolled chronic diseases (e.g., end-stage renal disease, cirrhosis, metastatic cancer, severe cardiovascular disease).
- Psychiatric disorders limiting adherence to post-operative care (e.g., severe depression, psychosis, substance use disorder).
- Pregnancy or breastfeeding (or plans for pregnancy within 12 months post-surgery).
- Allergy or intolerance to surgical materials, anesthesia, or post-operative medications required for the study.
- Inability to communicate or cooperate with study procedures (e.g., language barriers, cognitive impairment).
Trial locations and contacts
1 site in 1 country.
About this study
The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique), intends for decrease the rate of gastroesophageal reflux disease (GERD). This study aims to evaluate the influence of the Nissen Sleeve technique on GERD. However, the Ezisurg easyEndoTM Linear Cutting Stapler and Loading Units for Single Use were used in this study, and its safety and performance could be evaluated at the same time.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- Ezisurg stapler SLEEVE technique, Ethicon Stapler SLEEVE technique
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezisurg stapler SLEEVE techniqueProcedure or surgery
The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique)
Ethicon Stapler SLEEVE techniqueProcedure or surgery
The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique)
| Study group | Role | What they receive |
|---|---|---|
| Ezisurg stapler | Experimental | easyEndoTM Lite Linear Cutting Stapler (U12L60) and Loading Units (N60G) manufactured by Ezisurg Receives: Procedure: Ezisurg stapler SLEEVE technique |
| Ethicon Stapler | Active comparator | ECHELON™ Powered Stapler and reload (GST60G) manufactured by Johnson \& Johnson. Receives: Procedure: Ethicon Stapler SLEEVE technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients with GERD at 24 months
The main objective of the study was to evaluate the impact of Sleeve Gastrectomy procedure with a Nissen fundoplication (Nissen-Sleeve) on the rate of patients with GERD at 24 months.
Measured: 24 months
Secondary outcomes (7)
Surgery time
Measured: Perioperative/Periprocedural
Intra-operation incidents
Measured: Perioperative/Periprocedural
Hospital stays
Measured: Perioperative/Periprocedural
Rate of re-intervention
Measured: two-year
Rate of re-hospital
Measured: two-year
One-year Endoscopy finding
Measured: One-year
Early & Long term post-operative complication
Measured: two-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2022
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ezisurg Medical Co. Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344935
- Sponsor's protocol ID
- ESM-MDR-VIII 1005B
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT07344935
- Acronym / sponsor ID
- ESM-MDR-VIII 1005B
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Ezisurg Medical Co. Ltd.University, hospital or other
- Collaborators
- University Hospital, Montpellier
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 15 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.
The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique), intends for decrease the rate of gastroesophageal reflux disease (GERD). This study aims to evaluate the influence of the Nissen Sleeve technique on GERD. However, the Ezisurg easyEndoTM Linear Cutting Stapler and Loading Units for Single Use were used in this study, and its safety and performance could be evaluated at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezisurg stapler | Experimental | Procedure: Ezisurg stapler SLEEVE techniqueeasyEndoTM Lite Linear Cutting Stapler (U12L60) and Loading Units (N60G) manufactured by Ezisurg |
| Ethicon Stapler | Active comparator | Procedure: Ethicon Stapler SLEEVE techniqueECHELON™ Powered Stapler and reload (GST60G) manufactured by Johnson \& Johnson. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) ≥ 30 kg/m² (or BMI ≥ 27 kg/m² with at least one obesity-related comorbidity, e.g., type 2 diabetes, hypertension, dyslipidemia).
- Medically eligible for laparoscopic sleeve gastrectomy (LSG) or Nissan sleeve surgery, as determined by a multidisciplinary bariatric team (e.g., surgeon, endocrinologist, dietitian).
- Ability to understand and voluntarily sign written informed consent.
- Willingness to comply with post-operative follow-up protocols (e.g., dietary monitoring, clinical visits, laboratory tests).
Key exclusion criteria (8 listed)
- BMI < 30 kg/m² (or < 27 kg/m² without obesity-related comorbidities).
- Contraindications to laparoscopic surgery (e.g., severe abdominal adhesions, hemodynamic instability, uncorrected coagulopathy).
- History of major gastrointestinal surgery (e.g., gastric bypass, colectomy) or anatomical abnormalities precluding sleeve gastrectomy.
- Active or uncontrolled chronic diseases (e.g., end-stage renal disease, cirrhosis, metastatic cancer, severe cardiovascular disease).
- Psychiatric disorders limiting adherence to post-operative care (e.g., severe depression, psychosis, substance use disorder).
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 |
|---|---|---|
| Ezisurg stapler SLEEVE techniqueThe Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique) | Procedure or surgery | Ezisurg stapler |
| Ethicon Stapler SLEEVE techniqueThe Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique) | Procedure or surgery | Ethicon Stapler |
Primary outcome
The rate of patients with GERD at 24 months
Time frame: 24 months
The main objective of the study was to evaluate the impact of Sleeve Gastrectomy procedure with a Nissen fundoplication (Nissen-Sleeve) on the rate of patients with GERD at 24 months.
7 secondary outcomes
Surgery time
Time frame: Perioperative/Periprocedural
Intra-operation incidents
Time frame: Perioperative/Periprocedural
Hospital stays
Time frame: Perioperative/Periprocedural
Rate of re-intervention
Time frame: two-year
Rate of re-hospital
Time frame: two-year
One-year Endoscopy finding
Time frame: One-year
Early & Long term post-operative complication
Time frame: two-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ezisurg stapler SLEEVE technique and Ethicon Stapler SLEEVE technique in people with Gastroesophageal Reflux Disease (GERD), run by Ezisurg Medical Co. Ltd. at 1 site in France.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jan 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients with GERD at 24 months (time frame: 24 months). 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 15 Jan 2026.