ProVIDE Studies Post Exit Analysis

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07680543

Enrollment

Registered

2026-07-02

Start date

2026-09-30

Completion date

2029-07-31

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms

Keywords

BPH / LUTS

Brief summary

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

Detailed description

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

Interventions

DEVICEProVee Urethral Expander System

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

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 Subjects who withdrew consent or were withdrawn by site Study PI.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

Design outcomes

Primary

Measure	Time frame
Post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.	Up to 36 months

Contacts

CONTACTDiane Gargus

diane@proverummedical.com1-720-472-1504

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026