Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 6:57 AM
Study NCT ID:
NCT02527369
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2015-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the XP1100RF Therapy on Thighs Circumference Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-08-25', 'releaseDate': '2020-08-12'}, {'resetDate': '2020-09-30', 'releaseDate': '2020-09-10'}], 'estimatedResultsFirstSubmitDate': '2020-08-12'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-10', 'studyFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2015-08-17', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thighs Circumference Reduction from Baseline at 30 days Follow Up', 'timeFrame': '30 days Follow Up', 'description': 'The primary efficacy outcome measure is set to be a minimum of 80% of subjects at 30-day follow up evaluation to show thighs circumference reduction of ≥1 cm below the gluteal fold relative to the base line assessment.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '30 days Follow Up', 'description': 'Absence of adverse events (AE) associated with the treatment procedure. Safety evaluations of skin reaction in the treatment area would be conducted at every treatment and follow up visits.'}, {'measure': 'Adverse Events', 'timeFrame': '3 months Follow Up', 'description': 'Absence of adverse events (AE) associated with the treatment procedure. Safety evaluations of skin reaction in the treatment area would be conducted at every treatment and follow up visits.'}, {'measure': 'Subject satisfaction assessed by questionnaires', 'timeFrame': '30 days Follow Up', 'description': 'Subject satisfaction as assessed by questionnaires administered at 30 days follow up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fat Reduction', 'Lipolysis'], 'conditions': ['Thighs Circumferential Reduction', 'Subcutaneous Fat Cell Disruption']}, 'descriptionModule': {'briefSummary': 'This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive temporary reduction of thighs circumference by disruption of adipocyte cells.', 'detailedDescription': 'This study is a prospective, single-arm, open label study of thighs circumference reduction following 4 treatment sessions delivered once a week over a 4-week period. The objective of the study is to demonstrate the effectiveness of the treatment after 30-day in achieving thighs circumference reduction of ≥1 cm relative to the base line assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) of 20 to 35 kg/m2.\n* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss 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* Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.\n* Diabetics dependent on insulin or oral hypoglycemic medications\n* Known cardiovascular disease such as arrhythmias, congestive heart failure\n* Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.\n* Prior surgical interventions for body sculpting of thighs such as liposuction\n* Medical, physical or other contraindications for body sculpting/ weight loss\n* Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent\n* Any medical condition known to affect weight levels and/or to cause bloating or swelling\n* Active infection, wound or other external trauma to the area to be treated\n* Pregnant, breast feeding, or planning pregnant before the end of the study\n* Serious mental health illness\n* Active or recurrent cancer or current chemotherapy and/or radiation treatment\n* Negative affection to heat'}, 'identificationModule': {'nctId': 'NCT02527369', 'briefTitle': 'Effect of the XP1100RF Therapy on Thighs Circumference Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'BTL Industries Ltd.'}, 'officialTitle': 'Effect of the XP1100RF Therapy on Thighs Circumference Reduction', 'orgStudyIdInfo': {'id': 'Version1-713/2/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XP1100RF group', 'description': 'Subjects in the XP1100RF group will be treated with the XP1100RF device.', 'interventionNames': ['Device: XP1100RF']}], 'interventions': [{'name': 'XP1100RF', 'type': 'DEVICE', 'description': 'Treatment of adipose tissue within the fat layer with XP1100RF device.', 'armGroupLabels': ['XP1100RF group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Radina Denkova, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aesthe Beauty Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BTL Industries Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-12', 'type': 'RELEASE'}, {'date': '2020-08-25', 'type': 'RESET'}, {'date': '2020-09-10', 'type': 'RELEASE'}, {'date': '2020-09-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'BTL Industries Ltd.'}}}}