Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT05784558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-27
First Post:
2023-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify responders of IPSS change', 'timeFrame': '3 months post-treatment visit', 'description': 'Change of \\>3 points in IPSS score from baseline to the 3 months post-treatment visit.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of symptomatic BPH\n\nExclusion Criteria:\n\n* Prior surgical intervention for treatment of BPH\n* Unable or unwilling to give informed consent or unwilling to complete all required questionnaires and follow-up assessments'}, 'identificationModule': {'nctId': 'NCT05784558', 'acronym': 'RELIEF', 'briefTitle': 'RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeoTract, Inc.'}, 'officialTitle': 'RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up', 'orgStudyIdInfo': {'id': 'CP00022'}, 'secondaryIdInfos': [{'id': 'CP00022', 'type': 'OTHER', 'domain': 'NeoTract'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'UroLift System', 'description': 'Therapy to be treatment with the UroLift System.', 'interventionNames': ['Device: UroLift System']}, {'label': 'Watchful Waiting or BPH Medications', 'description': 'Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications.', 'interventionNames': ['Other: Watchful Waiting or BPH Medications']}, {'label': 'Other Surgical Intervention', 'description': 'Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.', 'interventionNames': ['Device: Other Surgical Intervention']}], 'interventions': [{'name': 'UroLift System', 'type': 'DEVICE', 'description': 'The UroLift System is a procedure that utilizes tiny implants to lift and hold the enlarged prostate tissue out of the way so it no longer blocks the urethra.', 'armGroupLabels': ['UroLift System']}, {'name': 'Watchful Waiting or BPH Medications', 'type': 'OTHER', 'description': 'Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications.', 'armGroupLabels': ['Watchful Waiting or BPH Medications']}, {'name': 'Other Surgical Intervention', 'type': 'DEVICE', 'description': 'Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.', 'armGroupLabels': ['Other Surgical Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeoTract, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}