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

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 Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease (GERD)
• Intervention / Treatment: Procedure: Ezisurg stapler SLEEVE technique; Procedure: Ethicon Stapler SLEEVE technique

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hérault
    • Montpellier, Hérault, France, 34295
      • Hôpital Français du Levant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ezisurg stapler; easyEndoTM Lite Linear Cutting Stapler (U12L60) and Loading Units (N60G) manufactured by Ezisurg	Procedure: Ezisurg stapler SLEEVE technique; 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)
Active Comparator: Ethicon Stapler; ECHELON™ Powered Stapler and reload (GST60G) manufactured by Johnson & Johnson.	Procedure: Ethicon Stapler SLEEVE technique; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgery time	Perioperative/Periprocedural
Intra-operation incidents	Perioperative/Periprocedural
Hospital stays	Perioperative/Periprocedural
Rate of re-intervention	two-year
Rate of re-hospital	two-year
One-year Endoscopy finding	One-year
Early & Long term post-operative complication	two-year

Collaborators and Investigators

• Sponsor: Ezisurg Medical Co. Ltd.
• Collaborators: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: ESM-MDR-VIII 1005B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No