Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT05183633
Status:
TERMINATED
Last Update Posted:
2025-02-06
First Post:
2021-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Was not able not determine a meaningful bioimpedance measurement that could be correlated to bladder fullness over time.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Urge to Urinate to Bioimpedance. Our clinical trial is an attempt to determine the correlation of bioimpedance measurements versus bladder pressure (fullness) taken at the same time during a normally scheduled urodynamic study.', 'timeFrame': 'Bioimpedance measurements are taken in real time simultaneously with urodynamic pressure measurements. Therefore, the time frame is "zero." Each measurement characterizes actual bioimpedance at that point in time.', 'description': "Our primary outcome is determining the correlation strength between the bladder's pressure measurements (acquired during a standard urodynamic study) and bioimpedance measurements. That is, we are trying to find if bladder bioimpedance is correlated to bladder fullness, where pressure is the clinically-accepted measurement of bladder fullness in a urodynamic study."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Susceptible to Falls']}, 'descriptionModule': {'briefSummary': 'A Pilot Study to Assess the Association between Human Bioimpedance Measurements and Clinical Urodynamic Procedures', 'detailedDescription': "The purpose of the study is to assess how well Curbell's Bladder Sensor device measuring bioimpedance correlates to urodynamic studies and the reported sensation subjects feel when reporting bladder fullness and their urge to urinate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that have been previously scheduled for a urodynamic study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that have been previously scheduled for a Urodynamic Study\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05183633', 'briefTitle': 'A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Curbell Medical Products, Inc.'}, 'officialTitle': 'A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures', 'orgStudyIdInfo': {'id': 'HRP-503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'One single trial'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14225', 'city': 'Cheektowaga', 'state': 'New York', 'country': 'United States', 'facility': 'Western New York Urology Associates', 'geoPoint': {'lat': 42.90339, 'lon': -78.75475}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Curbell Medical Products, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}