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Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia (BPH)

29. juli 2026 opdateret af: Vivifi Medical

Safety and Efficacy Evaluation of the Vivifi Device for Treatment of Symptomatic Benign Prostatic Hyperplasia

The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The Vivifi Device and procedure will be an alternative treatment for symptomatic BPH. Where other currently available treatments are generally either procedures that destroy and/or remove prostatic tissue or that involve a minimally-invasive surgical therapy, the Vivifi device is a less invasive percutaneous approach that does not require urethral entry, tissue removal, or implants. By addressing a contributing root cause of prostatic growth through a minimally invasive percutaneous approach, unwanted enlargement of the prostate may be halted or reversed, without damage to the prostatic tissue or urethra.These initial clinical studies will test the safety and feasibility of this approach.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Panama
    • Provincia de Panamá
      • Panama City, Provincia de Panamá, Panama
        • Hospital Paitilla

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Male 45-80 years of age
  2. Diagnosed with Benign prostatic hyperplasia (BPH)
  3. Prostate volume: ≥ 40 ≤ 100 cc measured by MRI
  4. Qmax ≤ 10 mL/s on two measures (voided volume ≥ 125 mL)
  5. Assessment of future paternity plans
  6. Signed the study informed consent
  7. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12

Exclusion Criteria:

  1. Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy.
  2. Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable
  3. Intravesical prostatic protrusion (IPP) > 10 mm
  4. Post-void residual volume (PVR) > 200ml
  5. IPSS QoL score ≤ 3
  6. Prostate cancer diagnosis, suspicious DRE, or PSA > 10ng/mL
  7. Patients with clinical history of chronic prostatitis.
  8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days), or urethral strictures.
  9. Major neurological conditions such as Alzheimer's, Parkinsons, Multiple sclerosis, ALS, spinal cord injury
  10. Patients who are unable to undergo the required anesthesia for the procedure
  11. Patients on testosterone replacement therapy
  12. Patients unable to hold blood thinners, or with coagulation related issues
  13. Patients currently taking medication for BPH (eg. Alpha-blockers or 5-ARIs) who are unwilling or unable to discontinue (washout) prior to treatment (14 days for α-blockers (tamsulosin, alfuzosin, silodosin, doxazosin, terazosin), 8 weeks for finasteride, 5 months for dutasteride)
  14. Diagnosis of Hidradenitis suppurativa

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Minimally invasive percutaneous ablation
Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach
Enhed: Minimally invasive percutaneous ablation
Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Safety Endpoint
Tidsramme: 24 month follow-up
Number of participants experiencing device or procedure related adverse events assessed by severity and causality.
24 month follow-up
Mean change from baseline International Prostate Symptom Score (IPSS) at 24 months
Tidsramme: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
The IPSS is a validated 7-item questionnaire scored 0-25: higher scores indicate worse urinary symptoms. Mean change from baseline will be reported.
From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean change from baseline in ejaculatory function assessed by Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)
Tidsramme: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
The Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) is a validated, 4 item, patient-reported outcome instrument that assesses ejaculatory function and bother in men, evaluating domains of ejaculation force, volume, frequency, and satisfaction. A higher score on the first 3 domains indicates better ejaculatory function and the final domain indicates higher quality of life.
From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in prostate volume (cc) measured by MRI
Tidsramme: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in prostate volume (cubic centimeters) as measured by magnetic resonance imaging (MRI) at specified follow-up time points. A reduction in prostate volume is desirable.
From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in peak urinary flow rate (Qmax, mL/s) measured by uroflow
Tidsramme: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in peak urinary flow rate (Qmax, milliliters per second) as measured by uroflowmetry at specified follow-up time points.
From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in post-void residual volume (PVR, mL) measured by ultrasound or bladder scan
Tidsramme: Baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in post-void residual urine volume (PVR, milliliters) as measured by ultrasound or bladder scan at specified follow-up time points.
Baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procedure Duration
Tidsramme: Day of procedure
Time of procedure in minutes
Day of procedure
Change from baseline in serum PSA (ng/dl) and testosterone (ng/dl)
Tidsramme: Baseline, 1 month, 3 months, 6 months, 12 months, 24 months
Mean change from baseline in serum prostate-specific antigen (PSA, nanograms per milliliter) and total testosterone (nanograms per deciliter) as measured by standard laboratory assay at specified follow-up time points.
Baseline, 1 month, 3 months, 6 months, 12 months, 24 months
Cystoscopic assessment of urethral and bladder integrity
Tidsramme: From baseline, 1 month, 3 months, 6 months, 12 months
Cystoscopic evaluation of urethral and bladder mucosal integrity at specified follow-up time points to assess for procedure-related anatomical changes or adverse findings.
From baseline, 1 month, 3 months, 6 months, 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vivifi Medical

Samarbejdspartnere

RQM Plus

Efterforskere

  • Studiestol: Daniel Root, MD

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juli 2026

Først opslået (Faktiske)

4. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIP-US-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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