Benign Prostatic HyperplasiaBPH EFFICACYNCT06601179
Evaluating the Safety and Efficacy of the "HIFU" High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia;
A study testing HIFU in people with Benign Prostatic Hyperplasia, run by EDAP TMS S.A. at 9 sites in France.
Trial summary
Prostate adenoma, also known as benign prostatic hypertrophy or hyperplasia (BPH), involves an increase in the size of the prostate, forming a benign tumor. It is the most common benign tumor in men, generally affecting those over 40 years old. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- HIFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesFrance
- Study dates
- 23 Aug 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged ≥ 50 to ≤ 85
- Patient diagnosed with benign prostatic hyperplasia evaluated by:
- Prostate volume ranging from 30 cc to 80 cc evaluated by MRI
- Qmax < 15ml/s
- IPSS ≥ 8
- IPSS-QoL ≥ 3
- IIEF-5 > 17
- Patient for whom medical treatment failed (having been taken regularly for more than 12 weeks) OR patient with a contraindication to the initiation of medical treatment OR patient refusing medical treatment Patient whose prostate show no sign of cancerous lesion confirmed by MRI Patient capable of reading and understanding French or with a carer who speaks French and could help the patient understand the leaflet and the questionnaires Patient registered with a social security scheme Patient having given their free and informed consent to participate in the study
Who cannot join
- Presence of a median lobe preventing the HIFU treatment to be delivered according to the investigator's judgment Prostate cancer confirmed or suspected History of surgical treatment of the prostate History of radiotherapy of the prostate History of bladder cancer History of urethral stricture Presence of a urinary tract fistula Urethral stricture or untreated bladder neck stenosis Untreated urinary lithiasis Neurological bladder or neurological bladder disease or any other neurological disease likely to affect the functioning of the bladder-sphincter system History of pelvic radiotherapy Patient with renal failure with GFR < 35ml/min Patient currently undergoing anticoagulant therapy (antivitamins K (AVK) and new oral anticoagulants (NOACs) for which the stop window cannot exceed 48H at the time of the HIFU procedure Contraindication to the surgical procedure, in particular anesthesia Contraindication to the pelvic MRI Patient with a rectal wall > 10mm
- Contraindication to the HIFU treatment procedure:
- Active urogenital infection (the infection must be treated before HIFU treatment)
- Anal or rectal fibrosis, anal or rectal stenosis or any other abnormalities making it difficult to insert the Focal One® probe
- Urinary tract or rectal fistula
- Anatomic abnormalities of the rectum or rectal mucosa
Show all 12Show fewer
- Presence of permanent radioactive implants in the rectal wall
- Presence of prostatic calcification the location of which interferes with the HIFU treatment
- Patient with an artificial sphincter, a penile prosthesis or intra-prostatic implant; for example, an endoprosthesis
- Presence of an implant (stent, catheter) within 1cm of the treatment area
- History of inflammatory bowel disease
- Presence of metal stents or implants in the urethra Patient refusing to participate in the study Person under guardianship considered legally incapable of giving their informed consentPatient unable or refusing to complete the questionnaires Persons placed under judicial protection Subject participating in another study including an exclusion period that is still running at the time of pre-inclusion
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
Clinique Saint Vincent
Besançon, 25000
Vincent Bailly, Dr, +330381472111, docteur.bailly.urologie@gmail.com
Vincent Bailly, Dr
- Not yet recruiting
Clinique Tivoli-Ducos
Bordeaux, 33000
Gilles Pasticier, Dr, +330556901121, gillespasticier@gmail.com
Gilles Pasticier, Dr
- Not yet recruiting
Groupe Hospitalier Pellegrin
Bordeaux, 33000
Franck Bladou, Pr, +330557820370, franck.bladou@chu-bordeaux.fr
Franck Bladou, Pr
- Not yet recruiting
CHU de Lille
Lille, 59000
Jonathan Olivier, Dr, +330320444173, jonathan.olivier@chu-lille.fr
Jonathan Olivier, Dr
- Recruiting
HCL_Hôpital Edouard Herriot
Lyon, 69003
Hakim Fassi-Fehri, Dr, +3304111140, hakim.fassi-fehri@chu-lyon.fr
Hakim Fassi-Fehri, Dr
- Recruiting
CH Matigues
Martigues, 13500
Harry Toledano, Dr, +3304 42 43 20 11, Harry.TOLEDANO@ch-martigues.fr
Harry Toledano, Dr
- Not yet recruiting
Hôpital Foch
Suresnes, 92150
Tarek Ghoneim, Dr, +330146252834, t.ghoneim@hopital-foch.org
Tarek Ghoneim, Dr
- Not yet recruiting
Clinique Saint Michel
Toulon, 83100
Stéphane Mallick, Dr, +3304 98 00 18 69, mallick@orange.fr
Stéphane Mallick
- Not yet recruiting
Hôpitaux de Toulouse
Toulouse, 31400
Mathieu Roumiguié, Dr, +330561322748, roumiguie.m@chu-toulouse.fr
Mathieu Roumiguié, Dr
About this study
Official title: Phase 1-2 Dose-escalation Study, Evaluating the Safety and Efficacy of the "HIFU" High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia After 3 Months, 6 Months, 12 Months, 18 Months and 36 Months.
Prostate adenoma, also known as benign prostatic hypertrophy or hyperplasia (BPH), involves an increase in the size of the prostate, forming a benign tumor. It is the most common benign tumor in men, generally affecting those over 40 years old. The risk of BPH is more than 50% in men aged 50 to 60 and rises to 90% in men by age 80.
This hyperplasia leads to altered urinary flow and bladder outlet obstruction, referred to as "lower urinary tract symptoms" or LUTS, which become more frequent with age. These symptoms are categorized as obstructive or irritative. In the early stages, men with BPH may have difficulty starting urination and may feel as if their bladder is not completely empty. As a result, they need to urinate more often, especially at night, a condition known as nocturia. Additionally, the volume and velocity of the urinary flow may decrease significantly, as evidenced by flow measurements, and residual urine discharge may occur at the end of urination.
Read more
High-intensity focused ultrasound (HIFU) is a medical technique that uses high-intensity ultrasonic waves to treat various medical conditions, including malignant and benign tumors, without the need for invasive surgery or ionizing radiation. HIFU generates heat between 80° to 95°C at the focal point, causing necrosis of the targeted area with pinpoint accuracy. In urology, HIFU is used to treat prostate cancer in a minimally invasive manner, with focused ultrasounds delivered endorectally using a transducer that targets the treatment area with real-time monitoring.
Exclusively targeted HIFU treatment has been suggested for BPH, where localized necrosis of the side lobes reduces the volume of the prostatic transition zone, alleviating compression of the prostatic urethra and improving urinary symptoms.
This new study was initiated to evaluate the safety and efficacy of HIFU for BPH treatment.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- HIFU
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFUDevice
high-intensity focused ultrasound treatment of benign prostatic hyperplasia
| Study group | Role | What they receive |
|---|---|---|
| HIFU | Experimental | Not described Receives: Device: HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events
Phase 1
Presence of significant cavitation that may be associated with adverse effects. Repeated urethral involvement that could damage the urethra. Absence of serious adverse effects (Clavien-Dindo ≥ III) directly attributable to the HIFU treatment procedure at 3 months of follow-up.
Based on these elements, the scientific committee will analyze the cause-and-effect relationship between the indicators observed during treatment and the adverse effects.
Measured: 3 months
Rate of patients with two of the following criteria ( Δ Qmax ≥ 50%, Δ IPSS ≥30%, Homogeneous necrosis observed on MRI)
Phase 1
Efficacy :
Efficacy will be considered satisfactory if at least two of the following three conditions are met:
Significant improvement in the maximum flow defined by Δ Qmax ≥ 50% of the initial flow or by a removal of the urinary catheter or supra-pubic catheter in included patients with urinary retention.
Improvement in obstructive and irritative symptoms 3 months after treatment, defined by a reduction in the IPSS score defined by Δ IPSS ≥30% Homogeneous necrosis observed on MRI
Measured: 3 months
Rate of patients that meet the four evaluation criteria (Absence of AD Clavien-Dindo ≥ III + ΔQmax ≥ 50% + Δ IPSS ≥30% + IPSS-QoL score ≤2)
Phase 2
Efficacy of the treatment
To validate phase 2, 80% of patients are expected to meet the four evaluation criteria below after 6 months.
Evaluation of urinary symptoms, continence, the erectile function, postoperative complications using a composite "tetrafecta" score defined by 4 criteria:
- Absence of serious adverse effects relating to the HIFU procedure, Clavien-Dindo ≥ III after 6 months.
- Significant improvement in the maximum flow defined by ΔQmax ≥ 50% of the initial flow after 6 months, or by a removal of the urinary catheter after 3 months in included patients with urinary retention.
- Improvement in obstructive and irritative symptoms 6 months after treatment, defined by a reduction in the IPSS score defined by Δ IPSS ≥30%
- Improvement in quality of life 6 months after treatment defined by an IPSS-QoL score ≤2
Measured: 6 months
Secondary outcomes (11)
Rate of adverse events
Treatment safety 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months after treatment will be evaluated by:
The rate of patients who experienced at least one adverse event with a Clavien-Dindo grade ≥ III The rate of patients with an SAE linked to the procedure The rate of patients with an SAE linked to the MD The rate of patients with unscheduled consultation and/or secondary re-hospitalization due to problems in connection with the procedure or the MD
Measured: 36 months
Rate of patients with a significant decrease of prostate size
The impact of treatment on changes in prostate size will be evaluated by MRI and ultrasound 3 months, 6 months, 12 months after treatment.
Measured: 36 months
The impact of the HIFU treatment on the urinary flow
The impact of the HIFU treatment on the urinary flow will be evaluated by measuring Q max 1 month, 3 months, 6 months, 12 months after treatment defined by:
The rate of patient with ΔQmax ≥ 50% Rate of patients with removal of the urinary catheter after 3 months in included patients with urinary retention.
The rate of patients with Qmax ≥ 15 ml/s
Measured: 36 months
Rate of patients with a significant decrease of RPM
The impact of the HIFU treatment on bladder voiding will be evaluated by measuring RPM 1 month, 3 months, 6 months, 12 months after treatment, defined by:
The rate of patients with RPM ≤ 150 ml The rate of patients with Δ RPM ≥50%
Measured: 36 months
The rate of patients with a significant improvment of obstructive and irritative symptoms of the lower urinary tract
The effect of the treatment on the obstructive and irritative symptoms of the lower urinary tract will be evaluated using the IPSS score 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after treatment, defined by:
The rate of patients with Δ IPSS ≥30% The rate of patients with an IPSS score ≤ 7
Measured: 36 months
The rate of patients with a significant improvment of LUTS-related quality of life
The evaluation of the impact of the HIFU treatment on LUTS-related quality of life 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after treatment, defined by:
The rate of patients with an IPSS-QoL score ≤ 2
Measured: 36 months
The rate of patients with an improvment in the erectile function
The evaluation of the impact of treatment on the erectile function 1 month, 3 months, 6 months, 12 months and 36 months after treatment, defined by:
The rate of patients with a Δ IIEF score ≤ 5
Measured: 36 months
The evaluation of the impact of treatment on the ejaculatory function
The evaluation of the impact of treatment on the ejaculatory function 1 month, 3 months, 6 months, 12 months and 36 months after treatment, defined by:
The rate of patients with a Δ MSHQ-EjD score < 25 The rate of patients with MSHQ-EJD <10 (no ejaculatory dysfunction or mild dysfunction) The rate of patients who say they suffer from retrograde ejaculation
Measured: 36 months
The rate of patients with a recurrence over the follow-up period up to 36 months
The recurrence rate over the follow-up period up to 36 months will be evaluated by the number of patients with urinary retention who required catheterization or surgery for BPH.
Measured: 36 months
The cost related to the use of HIFU
The estimation of costs related to the use of HIFU will be carried out by calculating the costs associated with consumables, the time of medical staff directly involved in the procedure, and the duration of hospitalization.
Measured: 36 months
Efficiency
Efficiency will be estimated through the consideration of costs associated with HIFU treatment, follow-up costs, retreatments, and the duration of medical leave of absence.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Aug 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1 aims to determine the minimum effective dose for BPH treatment. It will include 10 patients receiving 50% of the standard shooting power. If, after a 3-month follow-up, there are no serious adverse events (SAEs) and good efficacy, Phase 2 will begin. If Phase 1 results indicate that 50% power is insufficient, power levels will be increased by 10% increments (60%, 70%, 80%, 90%) with similar follow-up until the minimum effective dose is determined. Phase 2 aims to validate the effocacy of the minimum effective dose. It will include 90 new patients treated with the same 50% power. They will be monitored regularly after 1 and 3 months, every 6 months up to 24 months, and finally at 36 months.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EDAP TMS S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601179
- Sponsor's protocol ID
- HIFU.F.23.02
- Acronym
- BPH EFFICACY
- Status last verified
- Oct 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2 Dose-escalation Study, Evaluating the Safety and Efficacy of the "HIFU" High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia After 3 Months, 6 Months, 12 Months, 18 Months and 36 Months.
- ClinicalTrials.gov ID
- NCT06601179
- Acronym / sponsor ID
- BPH EFFICACY / HIFU.F.23.02
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- EDAP TMS S.A.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate adenoma, also known as benign prostatic hypertrophy or hyperplasia (BPH), involves an increase in the size of the prostate, forming a benign tumor. It is the most common benign tumor in men, generally affecting those over 40 years old. The risk of BPH is more than 50% in men aged 50 to 60 and rises to 90% in men by age 80.
This hyperplasia leads to altered urinary flow and bladder outlet obstruction, referred to as "lower urinary tract symptoms" or LUTS, which become more frequent with age. These symptoms are categorized as obstructive or irritative. In the early stages, men with BPH may have difficulty starting urination and may feel as if their bladder is not completely empty. As a result, they need to urinate more often, especially at night, a condition known as nocturia. Additionally, the volume and velocity of the urinary flow may decrease significantly, as evidenced by flow measurements, and residual urine discharge may occur at the end of urination.
High-intensity focused ultrasound (HIFU) is a medical technique that uses high-intensity ultrasonic waves to treat various medical conditions, including malignant and benign tumors, without the need for invasive surgery or ionizing radiation. HIFU generates heat between 80° to 95°C at the focal point, causing necrosis of the targeted area with pinpoint accuracy. In urology, HIFU is used to treat prostate cancer in a minimally invasive manner, with focused ultrasounds delivered endorectally using a transducer that targets the treatment area with real-time monitoring.
Exclusively targeted HIFU treatment has been suggested for BPH, where localized necrosis of the side lobes reduces the volume of the prostatic transition zone, alleviating compression of the prostatic urethra and improving urinary symptoms.
This new study was initiated to evaluate the safety and efficacy of HIFU for BPH treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1 aims to determine the minimum effective dose for BPH treatment. It will include 10 patients receiving 50% of the standard shooting power. If, after a 3-month follow-up, there are no serious adverse events (SAEs) and good efficacy, Phase 2 will begin. If Phase 1 results indicate that 50% power is insufficient, power levels will be increased by 10% increments (60%, 70%, 80%, 90%) with similar follow-up until the minimum effective dose is determined. Phase 2 aims to validate the effocacy of the minimum effective dose. It will include 90 new patients treated with the same 50% power. They will be monitored regularly after 1 and 3 months, every 6 months up to 24 months, and finally at 36 months.
| Arm | Type | Receives |
|---|---|---|
| HIFU | Experimental | Device: HIFU |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men aged ≥ 50 to ≤ 85
- Prostate volume ranging from 30 cc to 80 cc evaluated by MRI
- Qmax < 15ml/s
- IPSS ≥ 8
- IPSS-QoL ≥ 3
Key exclusion criteria (12 listed)
- Presence of a median lobe preventing the HIFU treatment to be delivered according to the investigator's judgment Prostate cancer confirmed or suspected History of surgical treatment of the prostate History of radiotherapy of the prostate History of bladder cancer History of urethral stricture Presence of a urinary tract fistula Urethral stricture or untreated bladder neck stenosis Untreated urinary lithiasis Neurological bladder or neurological bladder disease or any other neurological disease likely to affect the functioning of the bladder-sphincter system History of pelvic radiotherapy Patient with renal failure with GFR < 35ml/min Patient currently undergoing anticoagulant therapy (antivitamins K (AVK) and new oral anticoagulants (NOACs) for which the stop window cannot exceed 48H at the time of the HIFU procedure Contraindication to the surgical procedure, in particular anesthesia Contraindication to the pelvic MRI Patient with a rectal wall > 10mm
- Active urogenital infection (the infection must be treated before HIFU treatment)
- Anal or rectal fibrosis, anal or rectal stenosis or any other abnormalities making it difficult to insert the Focal One® probe
- Urinary tract or rectal fistula
- Anatomic abnormalities of the rectum or rectal mucosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFUhigh-intensity focused ultrasound treatment of benign prostatic hyperplasia | Device | HIFU |
Primary outcome
Rate of adverse events
Time frame: 3 months
Phase 1 Presence of significant cavitation that may be associated with adverse effects. Repeated urethral involvement that could damage the urethra. Absence of serious adverse effects (Clavien-Dindo ≥ III) directly attributable to the HIFU treatment procedure at 3 months of follow-up. Based on these elements, the scientific committee will analyze the cause-and-effect relationship between the indicators observed during treatment and the adverse effects.
Rate of patients with two of the following criteria ( Δ Qmax ≥ 50%, Δ IPSS ≥30%, Homogeneous necrosis observed on MRI)
Time frame: 3 months
Phase 1 Efficacy : Efficacy will be considered satisfactory if at least two of the following three conditions are met: Significant improvement in the maximum flow defined by Δ Qmax ≥ 50% of the initial flow or by a removal of the urinary catheter or supra-pubic catheter in included patients with urinary retention. Improvement in obstructive and irritative symptoms 3 months after treatment, defined by a reduction in the IPSS score defined by Δ IPSS ≥30% Homogeneous necrosis observed on MRI
Rate of patients that meet the four evaluation criteria (Absence of AD Clavien-Dindo ≥ III + ΔQmax ≥ 50% + Δ IPSS ≥30% + IPSS-QoL score ≤2)
Time frame: 6 months
Phase 2 Efficacy of the treatment To validate phase 2, 80% of patients are expected to meet the four evaluation criteria below after 6 months. Evaluation of urinary symptoms, continence, the erectile function, postoperative complications using a composite "tetrafecta" score defined by 4 criteria: 1. Absence of serious adverse effects relating to the HIFU procedure, Clavien-Dindo ≥ III after 6 months. 2. Significant improvement in the maximum flow defined by ΔQmax ≥ 50% of the initial flow after 6 months, or by a removal of the urinary catheter after 3 months in included patients with urinary retention. 3. Improvement in obstructive and irritative symptoms 6 months after treatment, defined by a reduction in the IPSS score defined by Δ IPSS ≥30% 4. Improvement in quality of life 6 months after treatment defined by an IPSS-QoL score ≤2
11 secondary outcomes
Rate of adverse events
Time frame: 36 months
Rate of patients with a significant decrease of prostate size
Time frame: 36 months
The impact of the HIFU treatment on the urinary flow
Time frame: 36 months
Rate of patients with a significant decrease of RPM
Time frame: 36 months
The rate of patients with a significant improvment of obstructive and irritative symptoms of the lower urinary tract
Time frame: 36 months
The rate of patients with a significant improvment of LUTS-related quality of life
Time frame: 36 months
The rate of patients with an improvment in the erectile function
Time frame: 36 months
The evaluation of the impact of treatment on the ejaculatory function
Time frame: 36 months
The rate of patients with a recurrence over the follow-up period up to 36 months
Time frame: 36 months
The cost related to the use of HIFU
Time frame: 36 months
Efficiency
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU in people with Benign Prostatic Hyperplasia, run by EDAP TMS S.A. at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Djamila BENNAT (33472153142, affaires-cliniques@edap-tms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse events (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.