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Active, not recruitingPhase 3

Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy

Key facts

Who runs it
Krankenhaus Nordwest
Where
Germany4 sites in 1 countryChoose a country to see its sites
Trial code
Status
Active, not recruiting
Phase
Phase 3
People taking part
127 people, planned
Started
15 Jul 2020
Ended
Oct 2025
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy
  • Myomectomy (laparoscopic or open surgical)
Record updated
13 November 2024

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 35 criteriaShow less

Who can take part

  • Women with symptomatic and medically untreatable uterine fibroids who score at least 40 points on the Symptom Severity Score (SSS) of the Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS- QoL )
  • Safe access for the MRgFUS possible (anatomical position of the fibroids): Pelvic magnetic resonance imaging to document the number, location and size of fibroids and to exclude malignancy and other pelvic pathologies; necessary to determine whether MRgFUS can be performed technically (presence of a stable ultrasound window and exclusion of scars in the access path)
  • ≤ 5 fibroids requiring treatment
  • Fibroids with a diameter ≤ 10 cm
  • Total myoma volume ≤ 400 ml
  • Patient is suitable for treatment with MRgFUS-TUF as well as for myomectomy
  • Desire for least invasive treatment
  • Indication for hysteroscopy and fractionated abrasion depending on the bleeding pattern and endometrial thickness and structure have been critically tested in advance
  • inconspicuous cytological smear of the cervix uteri not older than 12 months
  • No previous uterine surgery / intervention
  • Female patients aged> 18 years. Patients of reproductive age must adhere to appropriate contraception until 6 months after the procedure. (Methods of contraception that meet the criteria of highly effective contraception in the sense of the Note for guidance on non- clinical safety studies for the conduct of human clinical trials for meet pharmaceuticals [CPMP / ICH / 286/95 mod ]). Patients of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
  • Karnofsky index ≥ 70
  • Given medical operability
  • Written consent of the patient

Who cannot take part

  • Presence of pacemaker or metal implants
  • Suspected Malignancy (absolute)
  • Serious internistic side-diseases or an acute infection
  • Chronic inflammatory bowel disease
  • Severe hepatic dysfunction (Aspartat-Aminotransferase (AST) / Transaminasen Alanin-Amino-transferase (ALT)> 3.5x ULN (upper limit of normal), Alkalische Phosphatase (AP)> 6xULN)
  • Active CHD (congenital heart disease), (symptoms present), cardiomyopathy or heart failure in NYHA (New York Heart Association) and EF (ejection fraction) stage III-IV <45%
  • Pretreatment with ulipristal acetate ( Esmya ) ≤ 2 months
  • Pregnancy (absolute)
  • acute inflammatory process (absolute)
  • Uterus myomatosis with more than 5 fibroids (relative, case-by-case decision)
  • Uterine fibroids with a diameter over 10 cm (absolute)
  • insufficient sound window can be reached for treatment (eg intestinal overlays, large scars in the acoustic window, very dorsal position of the fibroid)
  • subserous stalked fibroids
  • Inaccessible location of fibroids
  • Scarring in the treatment area
  • Recurring abortions
  • general contraindications to MR contrast agents
  • MRI contraindications
  • Karnofsky Index <70
  • Pregnancy or lactation
  • Participation in another interventional study

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The aim of the study is to answer the question, whether in patients with symptomatic and medically not sufficiently treatable uterine fibroids (population) the "Magnetic-Resonance-Guided Focused Ultrasound Surgery" short, MRgFUS-TUF (intervention) offers less burdensome therapy and patient-relevant advantages (symptom relief) compared to the operative myomectomy (comparison). The study will hence investigate the therapeutic benefit of this method.

The 2 groups in the trial

  • A MyomectomyExisting treatment, for comparison

    Removement of uterine fibroids by myomectomy

    Treatment: Myomectomy (laparoscopic or open surgical)

  • B MRgFUS-TUFTreatment being tested

    Removement of uterine fibroids by Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy (MRgFUS-TUF)

    Treatment: Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Multicenter, Randomized Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids (MRgFUS TUF) Compared to Myomectomy in Symptomatic Medication and Not Sufficiently Treatable Uterine Fibroids
Record updated
13 November 2024