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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2020-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Laser Prostatectomy Database and Registry

NCT00159406

Benign Prostatic Hyperplasia Enlarged Prostate

ACTIVE_NOT_RECRUITING

Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA

NCT04760483

Male Urogenital Diseases Genital Diseases, Male Prostatic Disease +1 more

ACTIVE_NOT_RECRUITING PHASE1

Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

NCT01500057

Benign Prostatic Hyperplasia (BPH)

COMPLETED PHASE4

Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH

NCT01218672

Benign Prostatic Hyperplasia

COMPLETED NA

Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia

NCT04198103

BPH Lower Urinary Tract Symptoms

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

BPH Prostate Hyperplasia Urinary Frequency/Urgency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FLA for BPH Active Treatment

Group Type EXPERIMENTAL

MRI Guided Transrectal Periuretheral Transitional Zone Ablation

Intervention Type DEVICE

Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI Guided Transrectal Periuretheral Transitional Zone Ablation

Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Visualase

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes