Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2025-12-28 @ 10:01 AM
Study NCT ID:
NCT01273961
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2011-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-08', 'studyFirstSubmitDate': '2011-01-07', 'studyFirstSubmitQcDate': '2011-01-07', 'lastUpdatePostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in cosmesis', 'timeFrame': '1 and 3 months', 'description': 'Improvement in cosmesis will be assessed by scoring photographs taken before and 1 and 3 months after treatment. Circumference changes will be measured and compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Laxity of Skin']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device used to treat and improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 21 to 70 years old,\n* For females, at least 9 months post-partum,\n* Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,\n* For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,\n* Apparently healthy,\n* Informed consent signed by the subject.\n\nExclusion Criteria:\n\n* History of skin hypersensitivity,\n* Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),\n* Use of non-steroidal anti-inflammatory drugs within past 2 weeks,\n* Suffering from hormonal imbalance which may affect weight or cellulite,\n* Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,\n* Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,\n* The current or recent use (within the past 12 months) of isotretinoin,\n* Pregnancy or breast feeding,\n* Infectious diseases (such as HIV) present,\n* Are a tobacco smoker,\n* Insulin dependent diabetic subjects,\n* Oxygen dependent subjects,\n* Subjects with severe chronic illness, scleroderma, or lupus,\n* Subjects with open sores or scars in the treatment region, or\n* Subjects with ischemia in the treatment region.'}, 'identificationModule': {'nctId': 'NCT01273961', 'briefTitle': 'Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rocky Mountain Biosystems, Inc.'}, 'officialTitle': 'Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring', 'orgStudyIdInfo': {'id': '0310-0003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AuraLevée treatment', 'type': 'DEVICE', 'description': 'A single treatment, on day 0, on each of no more than two treatment sites, using the AuraLevée device. Treatment sites are the face, abdomen, upper arm, thigh or neck.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Center for Cosmetic Surgery', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}], 'overallOfficials': [{'name': 'Andrew Wolfe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Cosmetic Surgery'}, {'name': 'Stephen Flock, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rocky Mountain Biosystems, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rocky Mountain Biosystems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}