MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)

April 1, 2024 updated by: Prostate Laser Center, PLLC
Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within the prostate under MRI guidance. This will be a single center, single arm prospective trial with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose to be part of the study will be enrolled consecutively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Prostate Laser Center, PLLC

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Diagnosis of lower urinary track symptoms (LUTS).
  2. Prostate volume of 40 - 200 cc.
  3. Men ≥ 45 years old.
  4. IPSS ≥ 15.
  5. BPH Impact Index ≥ 5.

Exclusion Criteria:

  1. History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer.
  2. Need to catheterize to relieve obstruction.
  3. Daily use of incontinence materials/padding.
  4. Neurogenic or hypotonic bladder, Parkinson's Disease, or a history of uncontrolled diabetes.
  5. Prior interventional or surgical treatment of BPH.
  6. Penile prosthesis.
  7. Artificial urinary sphincter or collagen bladder injection.
  8. Urethral stricture.
  9. Bleeding disorder/coagulopathy.
  10. Inability to refrain from blood thinners in the peri-procedural period.
  11. Inability or chooses not to provide informed consent.
  12. Any serious medical condition which would make proceeding to treatment unsafe.
  13. Significant contraindication to MRI or gadolinium contrast.
  14. Hip replacement.
  15. Lack of a rectum.
  16. Life expectancy of less than two years.
  17. Unable or unwilling to complete all required questionnaires and follow-up assessments.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FLA for BPH Active Treatment
Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation
Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Other Names:
  • Visualase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
International Prostate Symptom Score (IPSS) Change
Time Frame: From baseline to 2 months
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
From baseline to 2 months
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
Time Frame: From baseline to 2 months
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
From baseline to 2 months
BPH Impact Index Change
Time Frame: From baseline to 2 months
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
From baseline to 2 months
Sexual Health Inventory of Men (SHIM) Score Change
Time Frame: From baseline to 2 months
This survey rates erectile function from 0 (no function) to 25 (full function)
From baseline to 2 months
Number of Adverse Events
Time Frame: Continuous until completion of the study at 2 years
We asked patients to self-report adverse events.
Continuous until completion of the study at 2 years
International Prostate Symptom Score (IPSS) Change
Time Frame: From baseline to 4 months
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
From baseline to 4 months
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
Time Frame: From baseline to 4 months
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
From baseline to 4 months
BPH Impact Index Change
Time Frame: From baseline to 4 months
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
From baseline to 4 months
Sexual Health Inventory of Men (SHIM) Score Change
Time Frame: From baseline to 4 months
This survey rates erectile function from 0 (no function) to 25 (full function)
From baseline to 4 months
International Prostate Symptom Score (IPSS) Change
Time Frame: From baseline to 6 months
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
From baseline to 6 months
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
Time Frame: From baseline to 6 months
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
From baseline to 6 months
BPH Impact Index Change
Time Frame: From baseline to 6 months
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
From baseline to 6 months
Sexual Health Inventory of Men (SHIM) Score Change
Time Frame: From baseline to 6 months
This survey rates erectile function from 0 (no function) to 25 (full function)
From baseline to 6 months
International Prostate Symptom Score (IPSS) Change
Time Frame: From baseline to 24 months
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
From baseline to 24 months
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
Time Frame: From baseline to 24 months
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
From baseline to 24 months
BPH Impact Index Change
Time Frame: From baseline to 24 months
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
From baseline to 24 months
Sexual Health Inventory of Men (SHIM) Score Change
Time Frame: From baseline to 24 months
This survey rates erectile function from 0 (no function) to 25 (full function)
From baseline to 24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prostate Laser Center, PLLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Prostate Laser Center BPH 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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Sponsors and Collaborators

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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