Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
Study NCT ID:
NCT00931359
Status:
COMPLETED
Last Update Posted:
2011-06-15
First Post:
2009-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006945', 'term': 'Hyperhidrosis'}], 'ancestors': [{'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kathyo@miramarlabs.com', 'phone': '408-940-8700', 'title': "Kathy O'Shaughnessy, PhD", 'organization': 'Miramar Labs'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Sham subjects exited the study at 6 months, so group comparisons are not possible for later timepoints.'}}, 'adverseEventsModule': {'timeFrame': 'Sham group subjects followed for 6 months post-treatment. Treatment group subjects followed for 12 months post-treatment', 'description': 'Only adverse events judged by investigator as being possibly, to definitely related to the device or procedure are listed.', 'eventGroups': [{'id': 'EG000', 'title': 'Sham Treatment', 'description': 'Subjects received a sham treatment in two treatment sessions.', 'otherNumAtRisk': 39, 'otherNumAffected': 3, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment With DTS-G2 System', 'description': 'Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.', 'otherNumAtRisk': 81, 'otherNumAffected': 13, 'seriousNumAtRisk': 81, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Altered sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Treatment', 'description': 'Subjects received a sham treatment in two treatment sessions.'}, {'id': 'OG001', 'title': 'Treatment With DTS-G2 System', 'description': 'Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Factors of treatment group and analysis center were considered', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days post-treatment', 'description': 'The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:\n\n1. \\- My underarm sweating is never noticeable and never interferes with my daily activities\n2. \\- My underarm sweating is tolerable but sometimes interferes with my daily activities\n3. \\- My underarm sweating is barely tolerable and frequently interferes with my daily activities\n4. \\- My underarm sweating is intolerable and always interferes with my daily activities', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population was used. Last Observation Carry Forward was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Treatment', 'description': 'Subjects received a sham treatment in two treatment sessions.'}, {'id': 'OG001', 'title': 'Treatment With DTS-G2 System', 'description': 'Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months post-treatment', 'description': 'The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:\n\n1. \\- My underarm sweating is never noticeable and never interferes with my daily activities\n2. \\- My underarm sweating is tolerable but sometimes interferes with my daily activities\n3. \\- My underarm sweating is barely tolerable and frequently interferes with my daily activities\n4. \\- My underarm sweating is intolerable and always interferes with my daily activities', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Treatment', 'description': 'Subjects received a sham treatment in two treatment sessions.'}, {'id': 'OG001', 'title': 'Treatment With DTS-G2 System', 'description': 'Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating.\n\n1. \\- My underarm sweating is never noticeable and never interferes with my daily activities\n2. \\- My underarm sweating is tolerable but sometimes interferes with my daily activities\n3. \\- My underarm sweating is barely tolerable and frequently interferes with my daily activities\n4. \\- My underarm sweating is intolerable and always interferes with my daily activities This outcome is only measured for the treatment group; sham group exited the study after 6 month visit.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Sham group subjects exited the study after the 6 month follow-up visit, so were not in the study at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Reported Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Treatment', 'description': 'Subjects received a sham treatment in two treatment sessions.'}, {'id': 'OG001', 'title': 'Treatment With DTS-G2 System', 'description': 'Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months post-treatment', 'description': 'Adverse events were defined in the protocol and included anticipated side effects of the procedure. These events were tracked by the clinical site and did include subject-reported events. The events reported here only included side effects that were attributed by the principal investigator as being possibly to definitely related to the device or procedure. They did not include expected treatment effects, such as swelling or bruising in the treatment area.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham Treatment', 'description': 'Subjects received a sham treatment in two treatment sessions.'}, {'id': 'FG001', 'title': 'Treatment With DTS-G2 System', 'description': 'Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham Treatment', 'description': 'Subjects received a sham treatment in two treatment sessions.'}, {'id': 'BG001', 'title': 'Treatment With DTS-G2 System', 'description': 'Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '32.2', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '32.8', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-13', 'studyFirstSubmitDate': '2009-06-28', 'resultsFirstSubmitDate': '2011-04-15', 'studyFirstSubmitQcDate': '2009-06-30', 'lastUpdatePostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-13', 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.', 'timeFrame': '30 days post-treatment', 'description': 'The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:\n\n1. \\- My underarm sweating is never noticeable and never interferes with my daily activities\n2. \\- My underarm sweating is tolerable but sometimes interferes with my daily activities\n3. \\- My underarm sweating is barely tolerable and frequently interferes with my daily activities\n4. \\- My underarm sweating is intolerable and always interferes with my daily activities'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.', 'timeFrame': '6 months post-treatment', 'description': 'The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:\n\n1. \\- My underarm sweating is never noticeable and never interferes with my daily activities\n2. \\- My underarm sweating is tolerable but sometimes interferes with my daily activities\n3. \\- My underarm sweating is barely tolerable and frequently interferes with my daily activities\n4. \\- My underarm sweating is intolerable and always interferes with my daily activities'}, {'measure': 'Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit', 'timeFrame': '12 months', 'description': 'The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating.\n\n1. \\- My underarm sweating is never noticeable and never interferes with my daily activities\n2. \\- My underarm sweating is tolerable but sometimes interferes with my daily activities\n3. \\- My underarm sweating is barely tolerable and frequently interferes with my daily activities\n4. \\- My underarm sweating is intolerable and always interferes with my daily activities This outcome is only measured for the treatment group; sham group exited the study after 6 month visit.'}, {'measure': 'Percentage of Subjects With Reported Adverse Events', 'timeFrame': '6 months post-treatment', 'description': 'Adverse events were defined in the protocol and included anticipated side effects of the procedure. These events were tracked by the clinical site and did include subject-reported events. The events reported here only included side effects that were attributed by the principal investigator as being possibly to definitely related to the device or procedure. They did not include expected treatment effects, such as swelling or bruising in the treatment area.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['axillary', 'hyperhidrosis', 'primary focal'], 'conditions': ['Primary Focal Hyperhidrosis, Axilla']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, parallel, randomized, blinded study. The study has two groups, where in one study group the subjects receive treatment for axillary hyperhidrosis (excessive underarm sweating) with the DTS-G2 System in both axilla ("treatment group"). The other study group receives a sham treatment in both axilla where the subjects will have the same procedure performed but no energy from the device will be applied ("sham group"). Subjects will be randomized in a 2:1 ratio (treatment group: sham group).\n\nSubjects enrolled in the study will be blinded regarding which study group they are in. The study hypothesis is that subjects that receive the treatment will have a reduction in underarm sweating compared to those in the sham group, as measured by a quality of life questionnaire.\n\nAll subjects will undergo follow up assessments at 14 days, 30 days, 3 months and 6 months post final treatment session. Subjects randomized to the treatment group will also have follow-up visits at 9 months and 12 months post final treatment session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* baseline gravimetric measurement of spontaneous resting sweat production of at least 50 mg/5 min at room temperature in each axilla\n* poor quality-of-life rating on the Hyperhidrosis Disease Severity Scale\n* primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria\n* female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study including follow-up period\n* female subjects over 40 must have had a mammogram in the last 2 years\n* subjects must be willing to comply with study visits and requirements\n\nExclusion Criteria:\n\n* subject has secondary hyperhidrosis (e.g., endocrinopathy, medications)\n* subject has active infection\n* subject is pregnant or lactating\n* subject has had prior surgery for axillary hyperhidrosis\n* subject has had axillary injections of botulinum toxin A in the last year\n* subject has used prescription antiperspirants in the last 14 days or plans to use them during the study period\n* subject has used oral anticholinergics in the last 4 weeks\n* subject is a prisoner or under incarceration\n* subject is participating in a another clinical trial (or has in the last 30 days)\n* subject has history of cancer (some exceptions)\n* subject has a pacemaker or other electronic implant\n* subject requires supplemental oxygen'}, 'identificationModule': {'nctId': 'NCT00931359', 'acronym': 'DRI-UP', 'briefTitle': 'Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Miramar Labs'}, 'officialTitle': 'A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis', 'orgStudyIdInfo': {'id': 'CP-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with DTS-G2 System', 'description': 'Subjects receive treatment with the DTS-G2 System (an energy-based medical device) in both axilla. Multiple treatment sessions may be used.', 'interventionNames': ['Device: DTS-G2 System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham treatment', 'description': 'All elements of the treatment are given except that no energy is delivered. Multiple treatment sessions may be used.', 'interventionNames': ['Device: DTS System (Sham treatment)']}], 'interventions': [{'name': 'DTS-G2 System', 'type': 'DEVICE', 'description': 'Treatment with microwave energy', 'armGroupLabels': ['Treatment with DTS-G2 System']}, {'name': 'DTS System (Sham treatment)', 'type': 'DEVICE', 'description': 'Sham treatment - no energy is delivered', 'armGroupLabels': ['Sham treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Laser and Skin Surgery Center of Northern California', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94085', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Center for Plastic Surgery', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'The Coleman Clinic', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Skin Care Physicians', 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07044', 'city': 'Verona', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Dermatology Group', 'geoPoint': {'lat': 40.82982, 'lon': -74.24015}}], 'overallOfficials': [{'name': 'Dee Anna Glaser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Louis University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miramar Labs', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': "Kathy O'Shaughnessy, VP Clinical/Regulatory", 'oldOrganization': 'Miramar Labs, Inc'}}}}