Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-06 @ 9:42 AM
Study NCT ID:
NCT03270150
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2017-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2017-08-30', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit', 'timeFrame': '4 months', 'description': 'Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit.'}, {'measure': 'Occurrence of adverse events', 'timeFrame': '7 months', 'description': 'The occurrence of adverse events will be followed throughout the whole study.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of BTL-899 treatment for fat and circumference reduction in abdomen, as assessed by two blinded evaluators', 'timeFrame': '4 months', 'description': 'Evaluation of photographs before and after the treatment.'}, {'measure': 'Efficacy of the BTL-899 treatment for abdomen circumference reduction', 'timeFrame': '4 months', 'description': 'Evaluation of change in abdomen circumference using tape measurements in cm at all study visits after the first therapy.'}, {'measure': 'Ultrasound imaging', 'timeFrame': '4 months', 'description': 'Evaluation of ultrasound images.'}, {'measure': "Subject's satisfaction with study treatment", 'timeFrame': '4 months', 'description': "Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale)."}, {'measure': 'Therapy comfort during the study treatment.', 'timeFrame': '1 month', 'description': 'Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Improvement of Abdomen Appearance']}, 'descriptionModule': {'briefSummary': 'The study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.', 'detailedDescription': 'This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 21 years\n* Voluntarily signed informed consent form\n* BMI ≤ 35 kg/m2\n* Women of child-bearing potential are required to use birth control measures during the whole duration of the study\n* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation\n* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation\n\nExclusion Criteria:\n\n* Cardiac pacemakers\n* Cardiovascular diseases\n* Implanted defibrillators, implanted neurostimulators\n* Electronic implants\n* Disturbance of temperature or pain perception\n* Pulmonary insufficiency\n* Metal implants\n* Drug pumps\n* Malignant tumor\n* Hemorrhagic conditions\n* Septic conditions and empyema\n* Acute inflammations\n* Systemic or local infection such as osteomyelitis and tuberculosis\n* Contageous skin disease\n* Elevated body temperature\n* Pregnancy\n* Breastfeeding\n* Injured or otherwise impaired muscles\n* Scars, open lesions and wounds at the treatment area\n* Basedow's disease\n* Previous liposuction in the treatment area in the last six months\n* Abdominal wall diastasis\n* Unstable weight within the last 6 months\n* Previous body contouring treatments in the abdomen area in the last three months"}, 'identificationModule': {'nctId': 'NCT03270150', 'briefTitle': 'Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen', 'organization': {'class': 'INDUSTRY', 'fullName': 'BTL Industries Ltd.'}, 'officialTitle': 'Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen', 'orgStudyIdInfo': {'id': 'BTL-899L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BTL-899 Therapy Arm', 'description': 'BTL-899 therapy, 3 therapies', 'interventionNames': ['Device: BTL-899']}], 'interventions': [{'name': 'BTL-899', 'type': 'DEVICE', 'description': 'BTL-899', 'armGroupLabels': ['BTL-899 Therapy Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1700', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Aesthe Clinic', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BTL Industries Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}