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RecruitingNCT07680543Updated Nov 5, 2026

ProVIDE Studies Post Exit Analysis

An observational study in BPH With Symptomatic Lower Urinary Tract Symptoms, sponsored by ProVerum Medical. Recruiting at 1 site in United States. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by ProVerum Medical · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 5, 2026Now RecruitingFirst site in United States+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
25
Ages
45 Years and older
Sex
Male
01

Study summary

A study to collect data on the post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.

Read the detailed description

An analysis of US based subjects who exited from the ProVIDE or ProVIDE II studies.

02

Conditions studied

  • BPH With Symptomatic Lower Urinary Tract Symptoms

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Keywords

  • BPH / LUTS
03

In context

Prostatic Hyperplasia

827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

This study's planned enrollment of 25 is below the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

ProVerum Medical is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All US based subjects who exited from the ProVIDE or ProVIDE II studies.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. US based subjects previously enrolled in the ProVIDE Study or the ProVIDE II Bridging Study who had a ProVee device removed.
  • 2. Subjects who withdrew consent or were withdrawn by site Study PI.
  • 3. Subjects consented to make data available.

Exclusion criteria

Exclusion Criteria:

  • 1. Incomplete records available.
  • 2. Subjects who exited the studies due to restarting BPH medication while they were enrolled.
  • 3. Subjects who did not receive a ProVee in the ProVIDE Study or the ProVIDE II Bridging Study.
  • 4. Subjects who exited the studies due to prostate cancer.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
25 participants (estimated)
Patient registry
No

Groups and cohorts

  • Observational Group

    US based subjects who exited from the ProVIDE or ProVIDE II studies.

    Device: ProVee Urethral Expander System

Interventions

  • DeviceProVee Urethral Expander System

    ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.

    Also known as: ProVee Expander, ProVee

06

What researchers measure

Primary outcomes

  1. Post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.

    Time frame: Up to 36 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — No plan to make individual participant data (IPD) available to other researchers

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 5, 2026
Sites
1 site added — first site in United States
Show site
  • Comprehensive Urologic Care · Lake Barrington, United States
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • Comprehensive Urologic Care · Lake Barrington, United States
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07680543
Lead sponsor
ProVerum Medical
Responsible party
Sponsor
First posted
Jul 2, 2026
Start date
Sep 30, 2026
Primary completion
Jul 31, 2029 (estimated)
Completion
Jul 31, 2029 (estimated)
Last update
Nov 5, 2026

Study contacts

Diane Gargus
Contact
diane@proverummedical.com
1-720-472-1504

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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