HIFU treatment
DeviceHIFU Treatment of rectal endometriosis
NCT Number: NCT04494568
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.
The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.
Looking for future studies?
Notify Me25 year and older
Female
Interventional
Not applicable
CHU de Angers, Angers, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HIFU Treatment of rectal endometriosis
Time frame: 6 months
The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment
Time frame: at 1 month, 3 months and 6 months post-intervention
EVA symptom Questionnaires
Time frame: at 1 month, 3 months and 6 months post-intervention,
Quality of life questionnaire : MOS- SF-36
Time frame: at 6 months
The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.
Time frame: during the fisrt 10 days post treatment.
The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.
Time frame: at 1 month, 3 months and 6 months post-intervention
Wexner
Time frame: at 1 month, 3 months and 6 months post-intervention
Kess questionnaires
Time frame: at 1 month, 3 months and 6 months post-intervention
SFSI questionnaire
Time frame: at 1 month, 3 months and 6 months post-intervention
USP questionnaire
EDAP TMS S.A.
Industry
Acronym: ENDO-HIFU-R1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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