Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-28 @ 11:39 PM
Study NCT ID:
NCT00953160
Status:
TERMINATED
Last Update Posted:
2023-09-18
First Post:
2009-08-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071697', 'term': 'Cellulite'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aturley@cutera.com', 'phone': '415-657-5665', 'title': 'Ayse Turley, Clinical Development Researcher', 'organization': 'Cutera Inc.'}, 'certainAgreement': {'otherDetails': '"The Doctor will not publish or present the results of the Study, or speak publicly about it, unless Cutera has first had a reasonable opportunity to review and comment on the contents of the proposed presentation or publication."', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination of the study resulting in analysis of small numbers of subjects, and technical issues with repeatability and reproducibility of circumference measurements leading to termination.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Subjects were assessed and followed up for adverse events at 6 weeks, 3 months and 6 months after the RF treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Radiofrequency (RF) Treatment', 'description': 'Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)', 'otherNumAtRisk': 49, 'otherNumAffected': 3, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lumps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 49, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Circumference (cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Treatment', 'description': 'Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)'}], 'classes': [{'title': 'Abdomen', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Thigh', 'categories': [{'measurements': [{'value': '0.6', 'spread': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Flank', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months post final treatment', 'unitOfMeasure': 'Centimeters (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Treatment', 'description': 'Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)'}], 'timeFrame': 'Baseline and 6 months post final treatment', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Treatment', 'description': 'Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)'}], 'classes': [{'title': 'Edema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lumps', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months after the last treatment', 'description': 'At each visit (treatment and follow-up) or until resolution of AEs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiofrequency (RF) Treatment', 'description': 'Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study subjects were recruited in the medical clinic 01/01/09 through 01/13/10.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiofrequency (RF) Treatment', 'description': 'Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '76', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '8.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'whyStopped': 'The preliminary data from this pilot study did not indicate efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2009-08-04', 'resultsFirstSubmitDate': '2011-02-25', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-02-25', 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Circumference (cm)', 'timeFrame': 'Baseline and 6 months post final treatment'}], 'secondaryOutcomes': [{'measure': 'Subject Satisfaction', 'timeFrame': 'Baseline and 6 months post final treatment'}, {'measure': 'The Number of Participants With Adverse Events', 'timeFrame': 'Up to 6 months after the last treatment', 'description': 'At each visit (treatment and follow-up) or until resolution of AEs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cellulite', 'Adipose tissue', 'Circumference', 'Reduction', 'Thigh', 'Abdomen', 'Flank'], 'conditions': ['Cellulite']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction in size of localized areas of the body.', 'detailedDescription': "The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction in size of localized areas of the body, including, but not limited to, areas on the abdomen, leg, and arm.\n\nAt investigator's discretion, each subject will receive up to three treatments and will be scheduled for two follow-up visits after the final treatment. The treated area will be measured and photographed ar each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or Male\n* Minimum age of 18 years\n* Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study.\n* Post-menopausal, or on birth control with no plans to become pregnant for the duration of the study (female only)\n* Minimum Body Mass Index of 20\n* Visible fat in the area to be treated Area to be treated to measure at least 20.0mm in vertical fold, as measured with industry standard fat caliper\n* Subject must be able to read, understand and sign the Consent Form\n* Subject must adhere to the follow-up schedule and study instructions\n* Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of initial weight)\n\nExclusion Criteria:\n\n* Significant weight fluctuation (+/-10 lbs) in the past 6 months\n* Taking weight-loss medications/supplements\n* Participation in any other clinical study\n* Cellulite treatment within 3 months of the treatment\n* Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction\n* Prior treatment to the target area within the last 12 months\n* Arteriosclerosis or weakened blood vessels\n* Heart disease\n* Thromboembolic disease\n* Diagnosed or documented immune system disorders\n* Bleeding disorders.\n* Presence of uncontrolled hypertension\n* Taking prescription anticoagulants\n* History of keloid formation\n* Malignant tumors in the target area\n* Diabetes\n* Any disease or condition that could impair wound healing\n* Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles\n* Infection in the target area\n* Implanted electrical device(s)\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT00953160', 'briefTitle': 'Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cutera Inc.'}, 'officialTitle': 'Pilot Study to Evaluate the Cutera RF Device for Reduction in Size of Localized Areas of the Body, Including, But Not Limited to, Areas on the Abdomen, Leg, and Arm', 'orgStudyIdInfo': {'id': 'C-09-TF-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RF treatment', 'description': 'Abdomen, flank or thigh treated with RF device', 'interventionNames': ['Device: Cutera Radio Frequency Device']}], 'interventions': [{'name': 'Cutera Radio Frequency Device', 'type': 'DEVICE', 'otherNames': ['Callisto, TruForm, TruSculpt'], 'description': 'Up to three treatments, one pass, dosage range of 15-60 kJ.', 'armGroupLabels': ['RF treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94506', 'city': 'Danville', 'state': 'California', 'country': 'United States', 'facility': 'Blackhawk Plastic Surgery', 'geoPoint': {'lat': 37.82159, 'lon': -121.99996}}, {'zip': '94568', 'city': 'Dublin', 'state': 'California', 'country': 'United States', 'facility': 'Renu LaserSpa', 'geoPoint': {'lat': 37.70215, 'lon': -121.93579}}, {'zip': '95825-6372', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Calkin/Boudreaux Dermatology Associates', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '07042', 'city': 'Montclair', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Plastic Surgery', 'geoPoint': {'lat': 40.82593, 'lon': -74.20903}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nashville Center for Laser and Facial Surgery', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Brian Biesman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jacqueline Calkin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stephen Ronan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Scott Kramer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Adele Makow, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Barry DiBernardo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cutera Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}