Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-17 @ 7:01 AM
Study NCT ID:
NCT02877667
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
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': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events', 'timeFrame': '1 day', 'description': 'Safety assessments included reported Adverse Events as a result of physician examination'}], 'secondaryOutcomes': [{'measure': 'Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos .', 'timeFrame': '12 weeks', 'description': 'The degree of fading assessed in terms of percentage fading (1-100%) and according to the following 1 to 5 scale:\n\n* 1 = 0%;\n* 2 = 1-25%;\n* 3 = 26-49%;\n* 4 = 50-75%; or\n* 5 = 76-100%'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tattoo', 'laser'], 'conditions': ['Tattoo']}, 'descriptionModule': {'briefSummary': 'Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.', 'detailedDescription': 'A non-significant risk, single center, prospective device trial to evaluate the number of passes of Q-Switch laser treatment that can be completed with a Q-Switch Laser alone compared to use of the Soliton Planar Acoustic Wave Device System (AWD) System as an accessory to Q-switched laser in tattoo reduction treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Range of Fitzpatrick skin color scores I to III\n* Tattoo with location on arms, legs, and torso only, and accessible to AWD treatment head. Black ink only. Other ink colors may be present, but areas of black only tattoo should meet criteria described as: minimum 1" x 3" tattoo with at least 30-50% consistent coverage (see fig 1).\n* Tattoo age between 1 and 20 years.\n* Professionally applied.\n\nExclusion Criteria:\n\n* Subject is pregnant or planning to become pregnant during the duration of the study.\n* Prior tattoo removal procedures on target tattoo.\n* Self-applied or amateur tattoo.\n* Tattoo layering (additional tattoo placed over an older tattoo to hide it) on target tattoo.\n* Metal or plastic implants in the area of the tattoo (pacemaker, implanted defibrillator, stent, or implants in the hips, knees, elbows, etc.).'}, 'identificationModule': {'nctId': 'NCT02877667', 'acronym': 'SOL1601', 'briefTitle': 'Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Soliton'}, 'officialTitle': 'Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol', 'orgStudyIdInfo': {'id': 'Soliton 2016-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open label device treatment', 'description': 'Up to four passes with Q-Switched laser alternating with acoustic wave device', 'interventionNames': ['Device: planar acoustic wave device']}], 'interventions': [{'name': 'planar acoustic wave device', 'type': 'DEVICE', 'otherNames': ['AWD'], 'description': 'accessory to laser treatment', 'armGroupLabels': ['Open label device treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'SkinCare Physicians', 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}], 'overallOfficials': [{'name': 'Chris Capelli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Soliton'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soliton', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MedSource LLC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}