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Completed

NCT Number: NCT07344935

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Français du Levant

Montpellier, Hérault, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ezisurg stapler SLEEVE technique

Procedure

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 technique

Procedure

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)

Primary outcomes

  1. The rate of patients with GERD at 24 months

    Time frame: 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.

Secondary outcomes

  1. Surgery time

    Time frame: Perioperative/Periprocedural

  2. Intra-operation incidents

    Time frame: Perioperative/Periprocedural

  3. Hospital stays

    Time frame: Perioperative/Periprocedural

  4. Rate of re-intervention

    Time frame: two-year

  5. Rate of re-hospital

    Time frame: two-year

  6. One-year Endoscopy finding

    Time frame: One-year

  7. Early & Long term post-operative complication

    Time frame: two-year

Sponsors and collaborators

Lead sponsor

Ezisurg Medical Co. Ltd.

Other

Collaborators

  • University Hospital, Montpellier

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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