Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:57 PM
Study NCT ID:
NCT07344935
Status:
COMPLETED
Last Update Posted:
2026-01-15
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of patients with GERD at 24 months', 'timeFrame': '24 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Surgery time', 'timeFrame': 'Perioperative/Periprocedural'}, {'measure': 'Intra-operation incidents', 'timeFrame': 'Perioperative/Periprocedural'}, {'measure': 'Hospital stays', 'timeFrame': 'Perioperative/Periprocedural'}, {'measure': 'Rate of re-intervention', 'timeFrame': 'two-year'}, {'measure': 'Rate of re-hospital', 'timeFrame': 'two-year'}, {'measure': 'One-year Endoscopy finding', 'timeFrame': 'One-year'}, {'measure': 'Early & Long term post-operative complication', 'timeFrame': 'two-year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease (GERD)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* 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).\n* Medically eligible for laparoscopic sleeve gastrectomy (LSG) or Nissan sleeve surgery, as determined by a multidisciplinary bariatric team (e.g., surgeon, endocrinologist, dietitian).\n* Ability to understand and voluntarily sign written informed consent.\n* Willingness to comply with post-operative follow-up protocols (e.g., dietary monitoring, clinical visits, laboratory tests).\n\nExclusion Criteria\n\n* BMI \\< 30 kg/m² (or \\< 27 kg/m² without obesity-related comorbidities).\n* Contraindications to laparoscopic surgery (e.g., severe abdominal adhesions, hemodynamic instability, uncorrected coagulopathy).\n* History of major gastrointestinal surgery (e.g., gastric bypass, colectomy) or anatomical abnormalities precluding sleeve gastrectomy.\n* Active or uncontrolled chronic diseases (e.g., end-stage renal disease, cirrhosis, metastatic cancer, severe cardiovascular disease).\n* Psychiatric disorders limiting adherence to post-operative care (e.g., severe depression, psychosis, substance use disorder).\n* Pregnancy or breastfeeding (or plans for pregnancy within 12 months post-surgery).\n* Allergy or intolerance to surgical materials, anesthesia, or post-operative medications required for the study.\n* Inability to communicate or cooperate with study procedures (e.g., language barriers, cognitive impairment).'}, 'identificationModule': {'nctId': 'NCT07344935', 'briefTitle': 'Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ezisurg Medical Co. Ltd.'}, 'officialTitle': 'Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'ESM-MDR-VIII 1005B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ezisurg stapler', 'description': 'easyEndoTM Lite Linear Cutting Stapler (U12L60) and Loading Units (N60G) manufactured by Ezisurg', 'interventionNames': ['Procedure: Ezisurg stapler SLEEVE technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ethicon Stapler', 'description': 'ECHELON™ Powered Stapler and reload (GST60G) manufactured by Johnson \\& Johnson.', 'interventionNames': ['Procedure: Ethicon Stapler SLEEVE technique']}], 'interventions': [{'name': 'Ezisurg stapler SLEEVE technique', 'type': 'PROCEDURE', 'description': '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)', 'armGroupLabels': ['Ezisurg stapler']}, {'name': 'Ethicon Stapler SLEEVE technique', 'type': 'PROCEDURE', 'description': '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)', 'armGroupLabels': ['Ethicon Stapler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'state': 'Hérault', 'country': 'France', 'facility': 'Hôpital Français du Levant', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ezisurg Medical Co. Ltd.', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Montpellier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}