ProVIDE Studies Post Exit Analysis | NCT07680543

Studies
ProVIDE Studies Post Exit Analysis

NCT07680543

Sponsor

ProVerum Medical

Status

Not yet recruiting

Last Update Posted

Jul 2, 2026Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms

Interventions

ProVee Urethral Expander System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2026Estimated

Primary Completion Date

Jul 31, 2029Estimated

Completion Date

Jul 31, 2029Estimated

First Submitted Date

Jun 18, 2026

First Submission Date that Met QC Criteria

Jun 25, 2026

First Posted Date

Jul 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2026

Last Update Posted Date

Jul 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational Group		US based subjects who exited from the ProVIDE or ProVIDE II studies.	Device: ProVee Urethral Expander System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ProVee Urethral Expander System	Device	ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.	Observational Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diane Gargus	Contact	1-720-472-1504		diane@proverummedical.com

Overall Officials

Not provided

Locations

Not provided

Label	URL
ProVerum Website	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

Not provided