NCT07344935

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Ezisurg Medical Co. Ltd. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: France