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Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy | Clinical Trials | Clareo Health

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Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy

NCT07344935•Ezisurg Medical Co. Ltd.

View on ClinicalTrials.gov

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). 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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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).

Locations (1)

Hôpital Français du Levant

Montpellier, Hérault, France

Key Dates

Start Date

January 1, 2022

Primary Completion Date

July 1, 2025

Completion Date

July 1, 2025

Last Updated

January 15, 2026

Enrollment

167

ACTUAL participants

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

Ezisurg stapler SLEEVE technique

PROCEDURE

Ethicon Stapler SLEEVE technique

PROCEDURE

Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease

NCT07179250

Incentive SpirometerDiaphragmatic Breathing+2 more

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COMPLETED

A Post-Approval Study of the LINX® Reflux Management System

NCT01940185

Gastroesophageal Reflux Disease (GERD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy

Inclusion Criteria

Exclusion Criteria

Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease

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