NCT04853914

Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.

Completed NA Last updated 5 June 2025

What this trial tests

NA trial testing HIFU treatment in Benign Prostatic Hyperplasia in 9 participants. Completed in 31 March 2024.

Timeline

13 September 2021

Primary endpoint
31 August 2023

31 March 2024

Quick facts

Lead sponsor	EDAP TMS S.A.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	13 September 2021
Primary completion	31 August 2023
Estimated completion	31 March 2024
Sites	1 location across France

Drugs / interventions tested

• HIFU treatment

Conditions studied

• Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →

Sponsor

EDAP TMS S.A.

Who can join

50 and older, male only, with Benign Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prostate adenoma or benign prostatic hypertrophy (BPH) is a benign disease of the prostate gland. It results in an increase in the volume of the prostate area located in contact with the urethra. Compression of the prostatic urethra by the adenoma can cause lower urinary tract disorders.

The classic treatments in case of failure of medical treatment are endoscopic resection of the prostate and adenomectomy, but these techniques are characterized by a significant hemorrhagic risk that may require transfusions and prolonged hospitalization.

Minimally invasive treatments with low morbidity have been developed to overcome these drawbacks. They allow to propose a therapeutic solution adapted to patients: not tolerating their medical treatment, wishing to keep antegrade ejaculation, elderly and/or frail, at risk of bleeding, wishing an ambulatory treatment, refusing the conventional surgical techniques.

The Focal One® device was developed to treat prostate cancer using ultrasound energy. This energy is delivered through a probe placed in your rectum. Connected to this probe, an ultrasound machine will allow your doctor to see precisely which part of your prostate is being treated. By heating the prostate tissue to a very high temperature in one treatment session, the energy delivered will then destroy the tissue. Ultrasound guidance coupled with the localized nature of the treatment allows the targeted area to be treated while respecting the prostate tissue and structures adjacent to the prostate and thus reducing side effects.

Treatment of prostate adenoma with HIFU would allow for localized destruction to reduce prostate volume. The reduction of the compression of the prostatic urethra thus obtained would allow an improvement of the urinary disorders. The treatment is performed transrectally under real-time ultrasound control, which allows the adjacent structures to be respected, thus preserving antegrade ejaculation and limiting the side effects.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immunomodulation and targeted drug delivery with high intensity focused ultrasound (HIFU): Principles and mechanisms.
   Ashar H, Ranjan A. · · 2023 · cited 41× · PMID 36965581 · DOI 10.1016/j.pharmthera.2023.108393