Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:13 AM
Study NCT ID:
NCT07485205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of vesical pressure (Pves)', 'timeFrame': 'Periprocedurally', 'description': 'Range of vesical pressure (Pves) in cm H2O as measured by the Glean Bladder Sensor'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lower Urinary Tract Symptoms (LUTS)']}, 'referencesModule': {'references': [{'pmid': '40314068', 'type': 'BACKGROUND', 'citation': 'Kim J, Xavier K, Cannon-Smith T, Vaughan T, Vemulapalli S, Zhao H, Aalami-Harandi A, Shah N. The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study. J Endourol. 2025 Jun;39(6):625-634. doi: 10.1089/end.2025.0270. Epub 2025 May 2.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, open-label, single arm interventional trial to establish normative reference ranges for urodynamics parameters in healthy adult participants using using the Glean Urodynamics System.', 'detailedDescription': 'Subjects will have the Glean Urodynamics System inserted for an in-clinic ambulatory monitoring period. Afterward, they will be discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, not exceeding 24 hours. The sensor will be removed within 24 hours of insertion. Subjects will receive a follow-up phone call 7 days post-removal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male and female adults ages 18 to 45 years.\n2. Patient is able to read, write, and communicate in English.\n3. Patient is able to provide informed consent.\n4. Patient owns, can independently operate, and is willing to use a smart device for study data collection purposes\n\nExclusion Criteria:\n\n1. Patient with any prior pregnancy (gravida ≥1), is currently pregnant (as confirmed by urine pregnancy test or medical history), or intends to become pregnant during the study period.\n2. Patient has one or more symptoms indicative of a symptomatic urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and/or dysuria).\n3. Patient has a known history of urological conditions (e.g., recurrent UTIs, incontinence, symptomatic benign prostatic hyperplasia, neurogenic bladder, interstitial cystitis, urinary retention, any genitourinary cancer).\n4. Patient has a known history of neurological conditions that can affect central nervous system function.\n5. Patients with a current or prior diagnosis of diabetes mellitus (Type 1 or Type 2).\n6. Patient is currently taking medications that may affect urological functions (e.g., diuretics, anticholinergics, alpha-blockers).\n7. Patient has abnormal urinary habits if one or more of the following bladder events are reported on any day of the 3-day bladder diary: urinary frequency ≥ 8 times/day, ≥ 1 nocturia episode, ≥ 1 leak event, or ≥ 1 urgency event.\n8. Patient has a total score on the Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10) questionnaire greater than 0; a total score of 1 is acceptable only if the sole positive response is urinary frequency of 4-7 times per day.\n9. Patient has a urostomy and/or colostomy.\n10. Patient has an atypical anatomic structural variation or has had a previous surgical intervention that has permanently changed structural anatomy anywhere along their lower urinary tract (urethra, pelvic floor, urethral sphincter, and/or bladder wall) that the principal investigator deems might compromise the placement or retention of the Glean sensors during the study (e.g., strictures).\n11. Patient has a Pelvic Organ Prolapse Quantification (POP-Q) of Grade III or higher (i.e., most distal portion of the prolapse protrudes more than 1 centimeter below the hymen).\n12. Patient would not be appropriate for this study as determined by the Principal Investigator.'}, 'identificationModule': {'nctId': 'NCT07485205', 'briefTitle': 'Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bright Uro'}, 'officialTitle': 'Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults', 'orgStudyIdInfo': {'id': 'CIP-0018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glean Urodynamics System', 'description': 'Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.', 'interventionNames': ['Device: Glean Urodynamics System']}], 'interventions': [{'name': 'Glean Urodynamics System', 'type': 'DEVICE', 'description': 'Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.', 'armGroupLabels': ['Glean Urodynamics System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'contacts': [{'name': 'Cameron Meek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Jaffee, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'contacts': [{'name': 'Director of Clinical Operations, Altitude Clinical Research', 'role': 'CONTACT', 'email': 'clinicalresearch@altitudeclinicalresearch.org', 'phone': '720-475-5728'}, {'name': 'Stephen B Siegel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Boulder Medical Center', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}], 'centralContacts': [{'name': 'Brittany Carter, DHSc, MPH', 'role': 'CONTACT', 'email': 'brittany@brighturo.com', 'phone': '949-202-5689'}, {'name': 'Suranjan Roychowdhury, PhD', 'role': 'CONTACT', 'email': 'suranjan@brighturo.com', 'phone': '949-202-5685'}], 'overallOfficials': [{'name': 'Brittany Carter', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bright Uro'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Proprietary data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bright Uro', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}