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

N/ACompletedNCT07344935
Ezisurg Medical Co. Ltd.167 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

167

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

Ezisurg stapler SLEEVE techniquePROCEDURE

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)

Ethicon Stapler SLEEVE techniquePROCEDURE

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)

Eligibility

Sex: ALL
Medical Language ↔ Plain English
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

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

Surgery time

Time frame: Perioperative/Periprocedural

Intra-operation incidents

Time frame: Perioperative/Periprocedural

Hospital stays

Time frame: Perioperative/Periprocedural

Rate of re-intervention

Time frame: two-year

Rate of re-hospital

Time frame: two-year

One-year Endoscopy finding

Time frame: One-year

Early & Long term post-operative complication

Time frame: two-year

Data from ClinicalTrials.gov

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