ProVIDE Studies Post Exit Analysis

NCT07680543 | Not Yet Recruiting FDA Device

• 1 other identifier: CIP-004
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Keywords

BPH / LUTS

Outcome Measures

Primary Outcomes (1)

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

  Up to 36 months

Study Arms (1)

Observational Group

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

Device: ProVee Urethral Expander System

Interventions

ProVee Urethral Expander System DEVICE

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

Also known as: ProVee Expander, ProVee

Observational Group

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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 Subjects who withdrew consent or were withdrawn by site Study PI.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

You may not qualify if:

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

Sponsors & Collaborators

• ProVerum Medical: lead

Related Links

• ProVerum Website

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Diane Gargus

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 2, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share