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

Ezisurg Medical Co. Ltd.

Status

Completed

Conditions

Gastroesophageal Reflux Disease (GERD)

Treatments

Procedure: Ezisurg stapler SLEEVE technique

Procedure: Ethicon Stapler SLEEVE technique

Study type

Interventional

Funder types

Other

Identifiers

NCT07344935

ESM-MDR-VIII 1005B

Details and patient eligibility

About

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.

Enrollment

167 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).