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New surgical stapler tested in GERD study shows promise

NCT ID NCT07344935

Disease control Sponsor: Ezisurg Medical Co. Ltd. Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special stapler during a combined weight-loss and anti-reflux surgery called Nissen Sleeve. It involved 167 people with obesity and GERD. The goal was to see if the surgery reduces acid reflux and if the stapler works safely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

167 people

The number who actually took part.

Started

Jan 2022

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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). Exclusion Criteria * 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).

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroesophageal reflux disease (GERD)

Contacts and locations

Locations

  • Hôpital Français du Levant

    Montpellier, Hérault, 34295, France

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