ProVIDE Studies Post Exit Analysis

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

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Key information

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Subjects who withdrew consent or were withdrawn by site Study PI.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

Treatment and study plan

ProVee Urethral Expander System

Device

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

Other names: ProVee Expander, ProVee

Primary outcomes

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

Time frame: Up to 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Gargus

CONTACT

[email protected]

1-720-472-1504

Sponsors and collaborators

Lead sponsor

ProVerum Medical

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jul 2, 2026
Registry last updated: Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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