Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 4:19 AM
Study NCT ID:
NCT06089759
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2023-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The performance of the cannulas for infiltration, fat harvesting or fat injection.', 'timeFrame': 'D0 (at intervention)', 'description': 'The success rate of cannulas defined by the capacity to infiltrate, harvest or inject.'}], 'secondaryOutcomes': [{'measure': "The surgeon's satisfaction with the procedure", 'timeFrame': 'D0 (at intervention)', 'description': 'The surgeon satisfaction will be assessed using a 4-point scale (likert scale) at intervention. (Very satisfied, Satisfied, Unsatisfied, Very unsatisfied). Very satisfied is the higher score and outcome.'}, {'measure': 'The safety of the cannulas during the intervention (All adverse device effects occurred during the intervention will be summarized)', 'timeFrame': 'D0 (at intervention)', 'description': 'All adverse device effects occurred during the intervention'}, {'measure': 'The safety of the intervention within the 1 month post intervention (All adverse events occurred from the intervention to the 1 month follow-up visit will be summarized)', 'timeFrame': 'D0 (at intervention) to month 1', 'description': 'All adverse events occurred from the intervention to the 1 month follow-up visit'}, {'measure': 'The usability of the cannulas during the intervention', 'timeFrame': 'D0 (at intervention)', 'description': 'Usability of the cannulas (easy to fit, …) assessed with a questionnaire (Scale of ease of fitting the cannula) in by the investigator (Very satisfied, Satisfied, Unsatisfied, Very unsatisfied). "Very satisfied" is the best value and outcome.'}, {'measure': 'The quality of life', 'timeFrame': 'At baseline and 1 month follow-up', 'description': 'Improvement of QoL score (numeric scale, 0 to 10, 10 is the maximum and the best value, 0 is the minimum value) at 1 month compared with pre-operative visit'}, {'measure': "The patient's satisfaction at 1 month (binary variable)", 'timeFrame': 'At 1 month', 'description': 'The proportion of patients who are satisfied at 1 month (binary variable, yes or no, yes is the best value)'}, {'measure': "The surgeon's satisfaction at 1 month", 'timeFrame': 'At 1 month', 'description': 'The proportion of patients for whom the surgeon is satisfied at 1 month'}, {'measure': 'The improvement of skin quality/aesthetic (likert scale)', 'timeFrame': 'At 1 month', 'description': 'The proportion of patients where the skin quality/aesthetic is improved at each follow-up visit. (Good improvement, mild improvement, no improvement, worsening, "good improvement" is the best value and outcome, "worsening" is the minimum value)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lipofilling', 'Liposuction', 'Fat injection', 'Repair and aesthetic surgery', 'Aesthetic body contouring'], 'conditions': ['Lipodystrophy', 'Deformities']}, 'descriptionModule': {'briefSummary': 'The purpose of this post-market clinical follow up study is to assess the safety and performance of Aesthetic Group cannulas. The study will evaluate the outcome of the Aesthetic Group cannulas range over a period of 1 month after intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population is directly linked to target population for autograft with Aesthetic group's cannulas", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age ≥ 18 years at intervention\n* Patient who will undergo a lipofilling treatment with at least one cannula of Aesthetic Group\n* Patient informed of his/her participation and willing to participate in the study.\n* Patient able to read, write and understand French.\n\nExclusion Criteria:\n\n* Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection\n* Patient unable to follow study procedures\n* Patient with hematologic abnormalities, prior radiotherapy or chemotherapy\n* Chronic use of medicines or drugs\n* Patient with diabetes mellitus\n* Patient with connective tissue diseases, any type of fat tissue disorder (lipodystrophy)\n* Patient with bleeding disorders; immune deficits; heart, liver, and kidney insufficiency\n* Patient with allergies to local anaesthetics\n* Patient with pacemaker and serious heart rhythm disorders\n* Pregnant and breastfeeding women'}, 'identificationModule': {'nctId': 'NCT06089759', 'briefTitle': 'Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesthetic Group'}, 'officialTitle': 'Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment', 'orgStudyIdInfo': {'id': 'LIPOTRANSFER'}}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'Clinique Phenicia', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75116', 'city': 'Paris', 'country': 'France', 'facility': 'Clinique Eiffel', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesthetic Group', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'EVAMED', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}