Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT04808206
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2021-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-18', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)', 'timeFrame': 'At index procedure', 'description': 'Number of conversions, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.'}, {'measure': 'Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)', 'timeFrame': 'At discharge up to 1 week', 'description': 'Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.'}, {'measure': 'Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)', 'timeFrame': 'Follow-up 1: 1 month after the procedure', 'description': 'Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.'}, {'measure': 'Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)', 'timeFrame': 'Follow-up 2: 6 months after the procedure', 'description': 'Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.'}, {'measure': 'Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)', 'timeFrame': 'Follow-up 3: 12 months after the procedure', 'description': 'Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.'}, {'measure': 'Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)', 'timeFrame': 'Follow-up 4: 24 months after the procedure', 'description': 'Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.'}], 'secondaryOutcomes': [{'measure': 'Device performance', 'timeFrame': 'At index procedure', 'description': 'Number of procedures with technical success'}, {'measure': 'Device performance', 'timeFrame': 'At index procedure', 'description': 'Scoring of: easy of intra-abdominal device positioning, grasping/climbing force, sharpness of the blades, staple-line formation, device stability, device maneuverability, device consistency and reliability, ergonomic design, hemostasis. Each of the aforementioned items receives a score from 0 to 4, with 0 indicating that the user is very unsatisfied and 4 indicating that the user is very satisfied.'}, {'measure': 'Clinical efficacy - weight loss', 'timeFrame': 'Follow-up 1: 1 month after the procedure', 'description': 'Weight loss'}, {'measure': 'Clinical efficacy - weight loss', 'timeFrame': 'Follow-up 2: 6 months after the procedure', 'description': 'Weight loss'}, {'measure': 'Clinical efficacy - weight loss', 'timeFrame': 'Follow-up 3: 12 months after the procedure', 'description': 'Weight loss'}, {'measure': 'Clinical efficacy - weight loss', 'timeFrame': 'Follow-up 4: 24 months after the procedure', 'description': 'Weight loss'}, {'measure': 'Number of participants with a post-operative change of cormorbidities', 'timeFrame': 'Follow-up 3: 12 months after the procedure', 'description': "Comorbidities (diabetes mellitus, peripheral arterial disease, coronary arterial disease, sleep disordered breathing, hypertension, dyslipidemia, hypercholesterolemia, hypertriglyceridemia, asthma, congestive heart failure, degenerative joint disease, gastroesophageal reflux, chronic obstructive pulmonary disease, use of immunosuppressants) 12 months after the surgical procedure as compared to the patients' comorbidities at baseline."}, {'measure': 'Number of participants with a post-operative change of cormorbidities', 'timeFrame': 'Follow-up 4: 24 months after the procedure', 'description': "Comorbidities (diabetes mellitus, peripheral arterial disease, coronary arterial disease, sleep disordered breathing, hypertension, dyslipidemia, hypercholesterolemia, hypertriglyceridemia, asthma, congestive heart failure, degenerative joint disease, gastroesophageal reflux, chronic obstructive pulmonary disease, use of immunosuppressants) 24 months after the surgical procedure as compared to the patients' comorbidities at baseline."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Roux-en-Y Gastric Bypass', 'Gastrostomy', 'Nissen Sleeve']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational registry is to evaluate the safety and the clinical efficacy of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical). The goal of the study will be achieved by reporting peri- and postoperative complications and the clinical outcome after surgery in a prospectively maintained database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese patients eligible for laparoscopic bariatric surgery. This registry will collect data from 250 laparoscopic bariatric procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥ 18 years of age at registry entry\n* Patient and investigator signed and dated the informed consent form prior to the index-procedure.\n* Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities.\n* Patient has a BMI ≥ 40 kg/m2.\n* Patient is eligible for laparoscopic bariatric surgery.\n\nExclusion Criteria:\n\n* Patient is unable/unwilling to provide informed consent.\n* Patient has a history of bariatric surgery.\n* Patient is unable to comply with the registry protocol or the proposed follow-up visits.\n* Patient has a contra-indication for laparoscopic bariatric surgery.'}, 'identificationModule': {'nctId': 'NCT04808206', 'acronym': 'STAP-JOLI', 'briefTitle': 'A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Duomed'}, 'officialTitle': 'A Multicentric Prospective Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy', 'orgStudyIdInfo': {'id': 'DM-PRO-ST2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese patients eligible for laparoscopic bariatric surgery', 'interventionNames': ['Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)']}], 'interventions': [{'name': 'easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)', 'type': 'DEVICE', 'description': 'Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for the creation of anastomoses during laparoscopic bariatric surgery manufactured by Ezisurg Medical.', 'armGroupLabels': ['Obese patients eligible for laparoscopic bariatric surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Genk', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg, campus St.-Jan', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Haine-Saint-Paul', 'country': 'Belgium', 'facility': 'Hôpital de Nivelles, groupe Jolimont', 'geoPoint': {'lat': 50.45544, 'lon': 4.1885}}, {'city': 'Maaseik', 'country': 'Belgium', 'facility': 'Ziekenhuis Maas en Kempen', 'geoPoint': {'lat': 51.09802, 'lon': 5.78379}}], 'overallOfficials': [{'name': 'Salvatore Lobue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital de Nivelles (groupe Jolimont), Haine-Saint-Paul, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duomed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}