ProVIDE Studies Post Exit Analysis

September 2, 2026 updated by: ProVerum Medical
A study to collect data on the post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Subjects who withdrew consent or were withdrawn by site Study PI.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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational Group
US based subjects who exited from the ProVIDE or ProVIDE II studies.
Device: ProVee Urethral Expander System
ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
Other Names:
  • ProVee Expander
  • ProVee

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProVerum Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 25, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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