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

NCT03948789 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: MARGI-T
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (2)

• WAI question 4

  Time to sustainably return to normal activities, based on the daily Work Activity Index (WAI) dimension, "Estimated Impairment of Disease Performance". The return to normal activities is considered to be given if the question "Hindrance of medical condition or injury at work?" (min max: 1: 'in my opinion, I am completely unable to work', 6: 'No Disability') is answered for at least three consecutive days with "No Disability" (6) or "I can do my job, but have complaints" (5).

  Until at least three consecutive days questionnaire was answered as indicated, up to 12 months

• Symptom Severity Score of the UFS-QoL

  The symptom severity is determined to be the co- primary endpoint for assessing therapeutic efficacy, based on the SSS (Symptom Severity Score) of the UFS-QoL (Uterine fibroid symptom and quality of life questionnaire). The co-primary assessment is performed 12 months after the primary treatment and for the evaluation the proportion of patients with at least 25 points improvement in the SSS is determined (0-100 scale, 100 indicating very strong symptoms, 0 no or low symptoms).

  12 months after treatment

Secondary Outcomes (12)

• Hospital stay in days

  12 months after treatment

• Pain according to visual analog scale

  12 months after treatment

• Number of Adverse Events (AEs)

  12 months after treatment

• Number of postinterventional/postsurgery treatment complications

  12 months after treatment

• Number of re-interventions

  12 months after treatment

Study Arms (2)

A Myomectomy

ACTIVE COMPARATOR

Removement of uterine fibroids by myomectomy

Procedure: Myomectomy (laparoscopic or open surgical)

B MRgFUS-TUF

EXPERIMENTAL

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

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

Interventions

Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy PROCEDURE

Magnetic Resonance Imaging-controlled high-focussed ultrasound

B MRgFUS-TUF

Myomectomy (laparoscopic or open surgical) PROCEDURE

Myomectomy (laparoscopic or open surgical)

A Myomectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Krankenhaus Nordwest: lead

Study Sites (4)

Krankenhaus Nordwest

Frankfurt am Main, Hesse, 60488, Germany

Location

FOKUS Radiologische Gemeinschaftspraxis

Göttingen, Germany

Location

Leipzig University

Leipzig, Germany

Location

Marienhospital

Stuttgart, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Leiomyoma

Interventions

Uterine Myomectomy; Laparoscopy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Study Officials

• Thorsten O Götze, PD Dr. med.

  Krankenhaus Nordwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: July 15, 2020
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)