Clinical Trials Logo
  1. Home
  2. Uterine Fibroids
  3. NCT02914704

Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)

Uterine Fibroids Clinical Trial

Official title:
Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)

Clinical Trial Summary

MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this study is to obtain more information on the systemic response of the body to the HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the UFS-QoL questionnaire.

Also new methods for improving patient selection as well as treatment efficacy will be evaluated in this study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02914704
Study type Interventional
Source Turku University Hospital
Contact Kirsi M Joronen, PhD
Email kirsi.joronen@tyks.fi
Status Recruiting
Phase N/A
Start date January 2016
Completion date December 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT01441635 - Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids Phase 2
Completed NCT00958334 - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Phase 2
Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A