Image

ProVIDE II Bridging Study

Recruiting
45 years of age
Male
Phase N/A

Powered by AI

Overview

The purpose of the ProVIDE II Bridging Study is to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to BPH.

Description

This is a prospective, multi-center, open-label, non-randomized bridging study to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to benign prostatic hyperplasia (BPH).

Eligibility

Inclusion Criteria:

  1. Males > 45 years of age
  2. IPSS of ≥ 13, IPSS V/S > 1 at baseline assessment
  3. Prostate volume of ≥ 30 cc and ≤ 80 cc
  4. Prostatic urethral L2 lengths ≥ 3.75 cm by TRUS
  5. Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS.

Exclusion Criteria:

  1. Void volume <125 ml; Qmax > 12 ml/s; PVR > 250 ml
  2. Obstructive median lobe defined by EITHER >10mm protrusion on sagittal mid-prostate plane as measured by TRUS OR an obstructive median lobe seen on cystoscopy e.g., 'ball valve''
  3. High bladder neck, with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction
  4. Anatomy that would prevent the apices of the ProVee from engaging with the lateral lobes e.g., high degree of bladder neck angulation such that the anterior bladder neck is not visible
  5. Acute urinary retention
  6. Known immunosuppression
  7. History of or suspected prostate or bladder cancer
  8. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction, including a SOC biopsy if indicated).
  9. Recent urinary tract stones OR widespread calcifications on the prostatic urethral wall, within 3 months of index procedure
  10. A history of prostatitis within the last two years
  11. Active or history of epididymitis within the past 3 months
  12. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes
  13. History of urinary retention within 12 months of baseline assessment
  14. Requiring self-catheterization to void
  15. An active urinary tract infection (UTI) at time of index procedure
  16. Gross haematuria, within 3 months of index procedure.
  17. Subjects with known allergy to nickel or titanium
  18. Life expectancy estimated to be less than 60 months
  19. Taking androgens, unless eugonadal state for at least 3 months or greater with a stable dosage for at least 2 months as documented by the Investigator
  20. Use of 5-alpha-reductase inhibitors (e.g., dutasteride, finasteride) within 6 months of baseline assessment
  21. Use of Phenylephrine / Pseudoephedrine within 24 hours of baseline assessment
  22. Use of alpha-blockers (e.g., Terazosin, Doxazosin, Alfuzosin, Tamsulosin) within 2 weeks of baseline assessment
  23. Use of estrogen or drug-producing androgen suppression (e.g. gonadotropin-releasing hormonal analogues) within 1 year of baseline assessment
  24. Use of antihistamines, anticonvulsants, and antispasmodics within 1 week of baseline assessment unless there is documented evidence that the patient was on the same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study)
  25. Use of anticholinergics or cholinergic medication within 2 weeks of baseline assessment
  26. Use of beta-blockers where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last 6 months)
  27. Use of Phosphodiesterase-5 Enzyme Inhibitors in doses for BPH within 2 weeks of baseline assessment.
  28. Current treatment with anticoagulants (e.g., coumadin or enoxaparin) or antiplatelet medications other than aspirin (e.g., clopidogrel, or alternative and ASA). Patient unable to stop taking anticoagulants and/or antiplatelets within 3 days prior to the procedure or coumadin at least 5 days prior to the procedure. Low dose aspirin ≤100mg/day not prohibited
  29. Future fertility concerns
  30. Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate; including penile implants
  31. Previous pelvic irradiation or radical pelvic surgery
  32. Previous rectal surgery (other than haemorrhoidectomy) or known history of rectal disease
  33. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
  34. Urethral pathologies that may prevent insertion of Delivery System
  35. Uncontrolled diabetes mellitus including Hgb AIC >8%
  36. Overactive bladder (OAB) requiring treatment by OAB medication
  37. Urinary incontinence
  38. Patients taking tri-cyclic antidepressants.
  39. Compromised renal function (i.e., serum creatinine >1.8 mg/dl or upper tract disease)
  40. Hepatic disorder, bleeding disorders or metabolic impairment that might confound the results of the study or have a risk to subject per investigator's opinion
  41. Any major comorbidities or presence of unstable conditions, e.g., uncontrolled HTN, NYHA Class III or IV, cardiac arrhythmias that are not controlled by medication/medical device, myocardial infarction within the past 6 months, COPD with FEV1 <50, renal illness that might prevent study completion or would confound study results
  42. Vulnerable populations such as incarcerated or institutionalized adults, inmates, patients with physical, psychological (such as developmentally delayed adults), or medical impairment that might, in the judgment of the Investigator, prevent study completion or comprehension, or may confound study results (including patient questionnaires)
  43. History or current medical condition that would result in an unacceptable patient risk if that subject were to be included in the study
  44. Any subject that is currently enrolled in another ongoing investigational study.

Study details

BPH With Symptomatic Lower Urinary Tract Symptoms

NCT06236802

ProVerum Medical

24 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.