Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT01842802
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2013-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Investigation of Non Invasive Fat Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054023', 'term': 'Lasers, Semiconductor'}, {'id': 'D053844', 'term': 'Lasers, Solid-State'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-27', 'studyFirstSubmitDate': '2013-04-26', 'studyFirstSubmitQcDate': '2013-04-26', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biopsy of Tissue Samples as a Measure of Effectiveness', 'timeFrame': '5 months post treatment', 'description': 'Biopsy of treated area will be obtained up to 5 months post treatment and will be histologically assessed for changes in adipocytes and surrounding tissue to determine effectiveness of device.'}, {'measure': 'Ultrasound Measurement to Evaluate Reduction of Fat', 'timeFrame': '5 months post treatment', 'description': 'Ultrasound of the treatment area will be performed and evaluated in comparison to baseline results to determine reduction of the subcutaneous fat layer.'}], 'secondaryOutcomes': [{'measure': 'Lipid level blood testing to evaluate changes post treatment', 'timeFrame': '5 months post treatment', 'description': 'Blood testing will be performed to evaluate changes in lipid levels post treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Subcutaneous Fat']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser to reduce the volume of fat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A healthy non-smoking male or female between 20-60 years of age\n* Subjects presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin\n* Subjects who will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis\n* Understand and accept the obligation associated with the procedure\n* Subjects with Fitzpatrick skin types I to III.\n* Subjects who are willing to consent to participate in the study will be asked to undergo biopsies, ultrasound measurements, and blood testing as outlined for each group and defined in section 6.0.\n* Subjects must agree to maintain the same diet and exercise regime throughout the study\n\nExclusion Criteria:\n\n* Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months\n* A history of allergic reactions to medications or anesthesia required for the procedure\n* A history of thrombophlebitis\n* A history of acute infections\n* A history of heart failure\n* Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti-inflammatories within 2 weeks pre treatment\n* Intolerance to anesthesia or medications to be prescribed before or after the procedure.\n* Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study including EMLA cream or percocet\n* Taking medications that are photosensitive\n* A history of keloid formation\n* A study subject must not be pregnant or have been pregnant in the last 3 months\n* The physician has the right to make determination of eligibility as he/she deems clinically significant based on standard of care treatment"}, 'identificationModule': {'nctId': 'NCT01842802', 'briefTitle': 'Clinical Investigation of Non Invasive Fat Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cynosure, Inc.'}, 'orgStudyIdInfo': {'id': 'CYN12-NIF-ABDM02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diode Laser Treatment Before Abdominoplasty', 'description': 'Patient will be treated with Diode Laser prior to abdominoplasty.', 'interventionNames': ['Device: Diode Laser']}, {'type': 'EXPERIMENTAL', 'label': 'YAG Laser Treatment Before Abdominoplasty', 'description': 'Patients will be treated with YAG prior to abdominoplasty', 'interventionNames': ['Device: YAG laser']}], 'interventions': [{'name': 'Diode Laser', 'type': 'DEVICE', 'description': 'Diode Laser for treatment of subcutaneous fat', 'armGroupLabels': ['Diode Laser Treatment Before Abdominoplasty']}, {'name': 'YAG laser', 'type': 'DEVICE', 'description': 'YAG laser for treatment of subcutaneous fat', 'armGroupLabels': ['YAG Laser Treatment Before Abdominoplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10306', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Aesthetic Pavilion', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}], 'overallOfficials': [{'name': 'Patricia Krantz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cynosure, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cynosure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}