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

NCT ID: NCT03948789

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2025-10-31

Brief Summary

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.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A Myomectomy

Removement of uterine fibroids by myomectomy

Group Type: ACTIVE_COMPARATOR

Myomectomy (laparoscopic or open surgical)

Intervention Type: PROCEDURE

Myomectomy (laparoscopic or open surgical)

B MRgFUS-TUF

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy

Intervention Type: PROCEDURE

Magnetic Resonance Imaging-controlled high-focussed ultrasound

Interventions

Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy

Magnetic Resonance Imaging-controlled high-focussed ultrasound

Intervention Type: PROCEDURE

Myomectomy (laparoscopic or open surgical)

Myomectomy (laparoscopic or open surgical)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Pretreatment with ulipristal acetate ( Esmya ) ≤ 2 months
• Suspected Malignancy (absolute)
• 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
• Presence of pacemaker or metal implants
• Karnofsky Index <70
• 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%
• Serious internistic side-diseases or an acute infection
• Chronic inflammatory bowel disease
• Pregnancy or lactation
• Participation in another interventional study

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Krankenhaus Nordwest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thorsten O Götze, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Nordwest

Locations

Krankenhaus Nordwest

Frankfurt am Main, Hesse, Germany

FOKUS Radiologische Gemeinschaftspraxis

Göttingen, , Germany

Leipzig University

Leipzig, , Germany

Marienhospital

Stuttgart, , Germany

Countries

Germany

Related Links

https://www.aerzteblatt.de/nachrichten/98991/Erster-G-BA-Auftrag-zu...1%20von%202%2027.11.2018%2014:10

Related Info

Other Identifiers

MARGI-T

Identifier Type: -

Identifier Source: org_study_id