Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy
NCT07344935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167
Last updated 2026-01-15
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.
Conditions
- Gastroesophageal Reflux Disease (GERD)
Interventions
- 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)
- 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)
Sponsors & Collaborators
-
University Hospital, Montpellier
collaborator OTHER -
Ezisurg Medical Co. Ltd.
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-01
- Primary Completion
- 2025-07-01
- Completion
- 2025-07-01
Countries
- France
Study Locations
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