Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy
NCT ID: NCT07344935
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
167 participants
INTERVENTIONAL
2022-01-01
2025-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ezisurg stapler
easyEndoTM Lite Linear Cutting Stapler (U12L60) and Loading Units (N60G) manufactured by Ezisurg
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)
Ethicon Stapler
ECHELON™ Powered Stapler and reload (GST60G) manufactured by Johnson \& Johnson.
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)
Interventions
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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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Ezisurg Medical Co. Ltd.
OTHER
Responsible Party
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Locations
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Hôpital Français du Levant
Montpellier, Hérault, France
Countries
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Other Identifiers
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ESM-MDR-VIII 1005B
Identifier Type: -
Identifier Source: org_study_id
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