Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 2:24 PM
Study NCT ID:
NCT05432232
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2022-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@histosonics.com', 'phone': '(877) 740-0543', 'title': 'Vice President of Clinical Affairs', 'organization': 'HistoSonics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Histotripsy treatment through 30 days', 'description': 'All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.', 'eventGroups': [{'id': 'EG000', 'title': 'HistoSonics Investigational System', 'description': 'The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Intestinal dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper aerodigestive tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Taste disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Subcapsular renal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary retention postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Effectiveness: Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'tumors', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HistoSonics Investigational System', 'description': 'The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 hours after the index procedure', 'description': 'Technical success, defined as complete coverage of the tumor as determined ≤36 hours post-index procedure by magnetic resonance imaging (MRI) or computerized tomography (CT). \\[Core Lab Adjudicated\\]', 'unitOfMeasure': 'percentage of tumors', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'tumors', 'denomUnitsSelected': 'tumors'}, {'type': 'PRIMARY', 'title': 'Primary Safety: Freedom From Index Procedure Related Major Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HistoSonics Investigational System', 'description': 'The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days Post-Index Procedure', 'description': 'Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure. \\[Clinical Events Committee Adjudicated\\]', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Technique Efficacy (Primary)', 'timeFrame': '90 days Post-Index Procedure', 'description': 'Percentage of targeted tumors successfully eradicated post-index procedure assessed via MRI or CT at 90-days post-index procedure without repeat Histotripsy \\[Core Lab Adjudicated\\]', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-05'}, {'type': 'SECONDARY', 'title': 'Technique Efficacy (Secondary)', 'timeFrame': '90 days Post-Index Procedure', 'description': 'Percentage of targeted tumors successfully eradicated post-index procedure assessed via MRI or CT at 90-days post-index procedure after repeat Histotripsy \\[Core Lab Adjudicated\\]', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-05'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HistoSonics Investigational System', 'description': 'The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.'}], 'periods': [{'title': 'Participant Screening', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Screen Failures', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Eligibility criteria met and participant was eligible for treatment with histotripsy.', 'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}, {'title': 'Treatment to 30-Day Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The trial enrolled participants between March 2023 and November 2024 at one (1) UK site. All eligible subjects who provided informed consent were considered enrolled. Only subjects enrolled and treated with the HistoSonics Investigational System were assessed for the primary endpoints. Follow-up beyond 30 days was ongoing at the time of primary endpoint analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HistoSonics Investigational System', 'description': 'The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.0', 'groupId': 'BG000', 'lowerLimit': '59.0', 'upperLimit': '79.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants treated with histotripsy'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-22', 'size': 197235, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-24T13:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a prospective, multi-center, single-arm, pilot trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2022-06-17', 'resultsFirstSubmitDate': '2025-10-24', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-18', 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness: Technical Success', 'timeFrame': 'Up to 36 hours after the index procedure', 'description': 'Technical success, defined as complete coverage of the tumor as determined ≤36 hours post-index procedure by magnetic resonance imaging (MRI) or computerized tomography (CT). \\[Core Lab Adjudicated\\]'}, {'measure': 'Primary Safety: Freedom From Index Procedure Related Major Complications', 'timeFrame': '30 days Post-Index Procedure', 'description': 'Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure. \\[Clinical Events Committee Adjudicated\\]'}], 'secondaryOutcomes': [{'measure': 'Technique Efficacy (Primary)', 'timeFrame': '90 days Post-Index Procedure', 'description': 'Percentage of targeted tumors successfully eradicated post-index procedure assessed via MRI or CT at 90-days post-index procedure without repeat Histotripsy \\[Core Lab Adjudicated\\]'}, {'measure': 'Technique Efficacy (Secondary)', 'timeFrame': '90 days Post-Index Procedure', 'description': 'Percentage of targeted tumors successfully eradicated post-index procedure assessed via MRI or CT at 90-days post-index procedure after repeat Histotripsy \\[Core Lab Adjudicated\\]'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Renal Cancer', 'Tumor, Solid', 'Kidney Cancer', 'Tumor', 'Tumor, Benign', 'Kidney Neoplasms']}, 'referencesModule': {'references': [{'pmid': '40295402', 'type': 'BACKGROUND', 'citation': 'Wah TM, Abdel-Hadi O, Brandon J, Bhambra B, Glencross H, Occidental J, Stones JM, Vasudev N, Bhattarai S, Cartledge J. Early Clinical Histotripsy Treatment of Renal Cell Carcinoma. Cardiovasc Intervent Radiol. 2025 Jun;48(6):883-885. doi: 10.1007/s00270-025-04023-9. Epub 2025 Apr 28. No abstract available.'}, {'pmid': '40295399', 'type': 'BACKGROUND', 'citation': 'Wah TM, Amaral JF, Laeseke PF. Treatment of Primary Solid Renal Tumours Using Histotripsy: Study Protocol for the CAIN Feasibility Trial. Cardiovasc Intervent Radiol. 2025 Jun;48(6):857-865. doi: 10.1007/s00270-025-04035-5. Epub 2025 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.', 'detailedDescription': 'This trial is a prospective, multi-center, single-arm pilot trial designed to evaluate the effectiveness and safety profile of the HistoSonics Investigational System in treating primary solid renal tumors. Following histotripsy treatment of the solid renal tumor, subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Additionally, subjects will be followed 180 days (6 months) post-index procedure, with evaluations at the 14-day, 30-day, 90-day, and 180-day time points to establish the efficacy and safety profile of the HistoSonics Investigational System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is ≥18 years of age.\n2. Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments.\n3. Subject is diagnosed with a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date.\n4. Subject can tolerate general anesthesia.\n5. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.\n6. Subject meets all the following functional criteria at ≤14 days prior to the planned index procedure date:\n\n * White Blood Cell (WBC) ≥3,000/mm3\n * Absolute Neutrophil Count (ANC) ≥1,200/mm3\n * Hemoglobin (Hgb) ≥9 g/dL\n * Platelet count ≥100,000/mm3 (≥100 10\\*9/L)\n * White Blood Cell (WBC) ≤40 cells/µL via urinalysis\n * Albumin ≤300,000 mg/L via urinalysis\n7. Subject has an eGFR ≥45mL/min, ≤14 days prior to the planned index procedure date.\n8. International Normalized Ratio (INR) score of \\<1.5:\n\n * If on anticoagulants, other than aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed on the day of the procedure; OR\n * If only on aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed ≤14 days prior to the planned index procedure date; OR\n * If not on anticoagulants, assessment must be performed ≤14 days prior to the planned index procedure date\n9. Biopsy is required to determine the type of tumor and must be performed ≥14 days prior to the planned index procedure date.\n10. The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.\n11. Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Investigational System.\n12. Subject will undergo histotripsy treatment of only one (1) tumor during the index procedure, regardless of how many tumors the subject has.\n\nExclusion Criteria:\n\n1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.\n2. Subject is enrolled and being actively treated in another investigational pharmaceutical or device trial ≤30 days prior to planned index procedure date.\n3. Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date.\n4. Subject is undergoing active immunotherapy ≤40 days prior to planned index procedure date.\n5. In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s) that would cause undue risk and preclude safe use of the HistoSonics Investigational System.\n6. Subject is on dialysis or being considered for dialysis.\n7. Subject has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or better from any adverse effects (except alopecia and neuropathy) related to previous anti-cancer therapy.\n8. Subject has an uncorrectable coagulopathy other than that induced by aspirin or non-steroidal anti-inflammatory drugs.\n9. Subject has a planned cancer treatment (e.g., nephrectomy, chemotherapy, immunotherapy etc.) prior to completion of the 30-day follow-up visit.\n10. Subject has had previous treatments with chemotherapy, radiotherapy, or both that have not been discontinued ≥14 days prior to the planned index procedure date and have not recovered (CTCAE grade 2 or better) from related toxicity (exclusive of alopecia and neuropathy).\n11. Subject has previous treatment with immunotherapies that has not been discontinued ≥40-days prior to the planned index procedure date and has not recovered from related toxicity (CTCAE grade 2 or better).\n12. Subject has a life expectancy less than one (\\< 1) year.\n13. In the investigator's opinion, histotripsy is not a treatment option for the subject.\n14. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.\n15. Subjects' targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, radiation).\n16. Subjects' tumor is not treatable by the HistoSonics Investigational System's working ranges (refer to User Guide).\n17. In the physician's opinion, the anticipated risk of intervention outweighs the potential benefits of the intervention.\n18. Subject has acute renal failure.\n19. Subject has a genetic predisposition to kidney cancer such as:\n\n * Von Hippel Lindau (VHL)\n * Hereditary Papillary Renal Carcinoma (HPRC)\n * Birt-Hogg-Dubé Syndrome (BHD)\n * Tuberous Sclerosis Complex (TSC)\n * Hereditary Leiomyomata's Renal Cell Carcinoma (HLRCC)\n * Reed's Syndrome\n * Succinate Dehydrogenase B Deficiency (SDHB)\n * BRCA 1 associated protein -1 (BAP1) Renal Cell Carcinoma\n * MITF predisposed Renal Cell Carcinoma\n20. Tumor is an angiomyolipoma.\n21. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.\n22. The targeted tumor is not clearly visible with diagnostic ultrasound and either magnetic resonance imaging (MRI) or computerized tomography (CT).\n23. Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, or other vital structure.\n24. Targeted tumor with adequate margin overlaps a non-targeted tumor visible via imaging.\n25. The treatment of the tumor will not allow for an adequate margin as determined by the investigator."}, 'identificationModule': {'nctId': 'NCT05432232', 'acronym': 'CAIN', 'briefTitle': 'The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'HistoSonics, Inc.'}, 'officialTitle': 'The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy', 'orgStudyIdInfo': {'id': 'CSP2276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HistoSonics Investigational System', 'interventionNames': ['Device: HistoSonics Investigational System']}], 'interventions': [{'name': 'HistoSonics Investigational System', 'type': 'DEVICE', 'otherNames': ['Histotripsy'], 'description': 'The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.', 'armGroupLabels': ['HistoSonics Investigational System']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HistoSonics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}