NCT07425015 Ambulatory Long Length URodynamics Evaluation
| NCT ID | NCT07425015 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bright Uro |
| Condition | Urology |
| Study Type | INTERVENTIONAL |
| Enrollment | 101 participants |
| Start Date | 2026-02-17 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 101 participants in total. It began in 2026-02-17 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective, open-label, single arm interventional trial evaluating the safety and performance of the in-clinic and extended monitoring of the lower urinary tract using the Glean Urodynamics System.
Eligibility Criteria
Inclusion Criteria: 1. Male or female patient must be ≥ 22 years of age. 2. Patient is a candidate for UDS per standard of care. 3. Patient is able to provide informed consent. Exclusion Criteria: 1. Patient has one or more symptoms indicative of a urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and/or dysuria). 2. Patient has a history of recurrent UTIs (≥ 3 episodes in previous 12 months). 3. Patient has used antibiotics within the past 7 days from the baseline/screening visit. 4. Patient diagnosed with neurogenic LUTD (i.e., one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine). 5. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS). 6. Patient with a urostomy. 7. Patient with a colostomy. 8. 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). 9. 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). 10. Patient with any abnormal or concerning rectal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, or active yeast infections. 11. Patient has a known inability to void. 12. Patient has a previous history of radiation leading to bleeding (e.g., hemorrhagic radiation cystitis). 13. Patient is pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months, or intending to become pregnant during the study period. 14. Patients who may not be able to independently use a smart device. 15. Subjects who, at the principal investigator's determination, would not be appropriate for this study.
Contact & Investigator
Brittany Carter, DHSc, MPH
STUDY DIRECTOR
Bright Uro
Frequently Asked Questions
Who can join the NCT07425015 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Urology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07425015 currently recruiting?
Yes, NCT07425015 is actively recruiting participants. Contact the research team at brittany@brighturo.com for enrollment information.
Where is the NCT07425015 trial being conducted?
This trial is being conducted at Hanover, United States, Owings Mills, United States, St Louis, United States, Cleveland, United States and 3 additional locations.
Who is sponsoring the NCT07425015 clinical trial?
NCT07425015 is sponsored by Bright Uro. The principal investigator is Brittany Carter, DHSc, MPH at Bright Uro. The trial plans to enroll 101 participants.