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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06375629
Other study ID # EDAP TMS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 20, 2023
Est. completion date April 20, 2027

Study information

Verified date March 2024
Source EDAP TMS S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 20, 2027
Est. primary completion date April 20, 2027
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient eligible for HIFU treatment for prostate cancer, excluding whole gland treatment. - Patient newly diagnosed with localized prostate cancer confirmed with an image guided biopsy (MRI and/or micro-ultrasounds). - Gleason = 4+3. - Patient scheduled for HIFU treatment as determined by the physician. - Patient with healthcare coverage. Spanish-speaking patients with the ability to provide informed written consent Exclusion Criteria: - Patient with bilateral prostate cancer requiring whole gland treatment. - Patients clinically detected metastasis. - Patient with an extension of cancer or seminal vesicle invasion. - Patient with contraindications for HIFU treatment: please refer to the complete Focal One user manual.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
FocalOne
The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device. This study is a non-interventional study. All the data will be collected from routine care. Data as indicated in the table below will be systematically recorded on the e-CRF to coincide with the scheduled follow-up visits at 3, 6 and 12 months.

Locations

Country Name City State
Spain Hospital Universitario Puerta del Mar Cadiz
Spain Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo Madrid
Spain Hospital Universitario Central De Asturias Oviedo
Spain Hospital Universitario Marqués De Valdecilla Santander
Spain Hospital Consorcio General Universitario de Valencia Valencia

Sponsors (1)

Lead Sponsor Collaborator
EDAP TMS S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of adverse events using the Clavien-Dindo classification 1 year
Primary Evaluation of quality of life IQL questionnaires 3, 6, 9 and 12 months
Primary Evaluation of urinary incontinence ICIQ questionnaire 3, 6, 9 and 12 months
Primary Erectile function assessment IIEF-5 questionnaire 3, 6, 9 and 12 months
Primary Urinary Symptoms IPSS questionnaire 3, 6, 9 and 12 months
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