Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:44 AM
Study NCT ID:
NCT07455058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Water Vapor Ablation for Prostate Cancer: Long-Term Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2041-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2041-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Efficacy Outcome', 'timeFrame': 'Through study completion, or up to 15 years.', 'description': 'Freedom from disease specific mortality.'}, {'measure': 'Primary Safety Outcome', 'timeFrame': 'Through study completion, or up to 15 years', 'description': 'Rate of complications classified as Clavien-Dindo grades III-V and attributable to the Vanquish procedure and/or device over time.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the registry is to evaluate real-world safety, efficacy, and patient reported outcomes among participants receiving Vanquish Water Vapor Ablation System therapy (Vanquish Therapy). This includes longitudinal assessment of patients who have received or will receive the therapy one or multiple times as part of routine clinical care and encompasses those who completed a company-sponsored Vanquish therapy study (as applicable).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be enrolled based on the inclusion/exclusion criteria listed. The Investigator(s) are responsible for determining if a patient is a candidate for therapy with the Vanquish System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidate for Vanquish therapy per physician discretion or participant has completed a company-sponsored Vanquish therapy study.\n* Participant is willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Contraindications per the Vanquish IFU\n* Previously participated in VAPOR 2 study and is not planning to receive further Vanquish therapy.'}, 'identificationModule': {'nctId': 'NCT07455058', 'acronym': 'VAPOR-LTR', 'briefTitle': 'Water Vapor Ablation for Prostate Cancer: Long-Term Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Francis Medical Inc.'}, 'officialTitle': 'Vanquish® Water Vapor Ablation for PrOstate CanceR: Long-Term Registry', 'orgStudyIdInfo': {'id': '5600-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vanquish Procedure Patients', 'description': 'Patients that have completed or will complete a Vanquish therapy and plan to continue their routine clinical care.', 'interventionNames': ['Device: Vanquish Therapy']}], 'interventions': [{'name': 'Vanquish Therapy', 'type': 'DEVICE', 'description': 'The Francis Medical, Inc. Vanquish Water Vapor Ablation Device ("Vanquish" or "Vanquish System") is a transurethral thermal water vapor ablation device. The Vanquish System is designed ablate prostate tissue, while minimizing side effects.', 'armGroupLabels': ['Vanquish Procedure Patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sydney Cartie', 'role': 'CONTACT', 'email': 'scartie@francismedical.com', 'phone': '6122866855'}, {'name': 'Garrett Grenier', 'role': 'CONTACT', 'email': 'ggrenier@francismedical.com', 'phone': '763-453-9404'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Francis Medical Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}