Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-11 @ 11:34 PM
Study NCT ID:
NCT03195920
Status:
TERMINATED
Last Update Posted:
2024-04-17
First Post:
2017-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014545', 'term': 'Urinary Calculi'}], 'ancestors': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm trial with the Enhanced Lithotripsy System'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Interim data was sufficient for study purpose', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in pain score', 'timeFrame': 'Baseline and Post Procedure Days 1, 2, 3, 7, 14, and 30', 'description': 'Pelvic Pain of the Patient (Min - Zero, Max - 10), Higher score means more pain'}, {'measure': 'Time to passage of stones', 'timeFrame': '30 days after last treatment session', 'description': 'Post-Treatment time to passage of stone fragments after treatment'}, {'measure': 'Pain medication usage', 'timeFrame': 'Baseline and Days 1, 2, 3, 7, 14, and 30', 'description': 'Use and quantity of pain medication'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects with serious device-related adverse events (safety)', 'timeFrame': '30 days after last treatment session', 'description': 'Safety: Proportion of subjects with serious device-related adverse events'}], 'secondaryOutcomes': [{'measure': 'Successful treatment of urinary stone', 'timeFrame': '14 days after last treatment session', 'description': 'Proportion of subjects with successful treatment or urinary stone'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Urinary Stone']}, 'descriptionModule': {'briefSummary': 'This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.', 'detailedDescription': 'This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones. Subjects will be treated up to 2 times with the Enhanced Lithotripsy System and followed for 30 days after the last treatment session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals presenting with one urinary stone-apparent on a computed tomography scan within the last 14 days\n* Males and females aged 18 or older\n* Capable of giving informed consent, and willing to have the informed consent process videotaped\n* Stone size, as estimated by pre-operative computed tomography, with all dimensions 15 mm or less.\n\nExclusion Criteria:\n\n* Individuals under 18 years of age\n* Individuals with radiolucent stones\n* Individuals with stones in the lower pole of kidney\n* Individuals not following up in the treating hospital\n* Individuals with history of cystinuria\n* Individuals with urine pH below 5.5\n* Individuals with untreated urinary tract infection\n* Individuals who are not willing to use adequate method of contraception during the study period\n* Women who are pregnant, lactating or planning pregnancy during the study period\n* Individuals with a coagulation abnormality or taking prescription anticoagulants.\n* Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side\n* Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)\n* Individuals with a body mass index greater than 35\n* Individuals with ASA score of 3 or greater general anesthesia risk level\n* Known sensitivity to possible medications used before, during, or after the treatment procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics'}, 'identificationModule': {'nctId': 'NCT03195920', 'briefTitle': 'Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avvio Medical'}, 'officialTitle': 'Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease', 'orgStudyIdInfo': {'id': '2017-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Lithotripsy System', 'description': 'Treatment for urinary stones with the Enhanced Lithotripsy System', 'interventionNames': ['Device: Enhanced Lithotripsy System']}], 'interventions': [{'name': 'Enhanced Lithotripsy System', 'type': 'DEVICE', 'description': 'The Enhanced Lithotripsy System is a type of lithotripsy system comprising a console, treatment head, and Acoustic Energy Focusing material. Operation of the Enhanced Lithotripsy System entails combined action of extracorporeal insonation and Acoustic Energy Focusing material to fragment urinary stones.', 'armGroupLabels': ['Enhanced Lithotripsy System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '387 001', 'city': 'Nadiād', 'state': 'Gujarat', 'country': 'India', 'facility': 'Muljibhai Patel Urological Hospital', 'geoPoint': {'lat': 22.69385, 'lon': 72.86157}}], 'overallOfficials': [{'name': 'Mahesh Desai, MS, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muljibhai Patel Urological Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avvio Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}