Recruiting

Observational Study

Sponsor:

ProVerum Medical

Code:

NCT07680543

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

Interventions

ProVee Urethral Expander System

Study Details

Brief summary:

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

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms

Study ID

NCT07680543

Start date

Sep 30, 2026

Status verified date

Nov, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

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 Subjects who withdrew consent or were withdrawn by site Study PI.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:

  • 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.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational Group

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

Interventions

ProVee Urethral Expander System

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

Primary outcome measure

  • Post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy. [ Time Frame: Up to 36 months ]

Central Contacts and Locations

Central contacts

Diane Gargus

1-720-472-1504diane@proverummedical.com

Locations

Comprehensive Urologic Care

Recruiting

Lake Barrington, Illinois, United States, 60010

More Information

Sponsor

ProVerum Medical

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Keywords

  • BPH / LUTS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by ProVerum Medical on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.