Uterine FibroidsPhase 3NCT03948789
Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy
A Phase 3 study testing Myomectomy (laparoscopic or open surgical) in people with Uterine Fibroids, run by Krankenhaus Nordwest at 4 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Myomectomy (laparoscopic or open surgical)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 4 sitesGermany
- Study dates
- 15 Jul 2020to Oct 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- 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)
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- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Krankenhaus Nordwest
Frankfurt am Main, Hesse, 60488
FOKUS Radiologische Gemeinschaftspraxis
Göttingen
Leipzig University
Leipzig
Marienhospital
Stuttgart
About this study
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
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
- Being tested
- Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy, Myomectomy (laparoscopic or open surgical)
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging-controlled high-focussed ultrasound therapyProcedure or surgery
Magnetic Resonance Imaging-controlled high-focussed ultrasound
Myomectomy (laparoscopic or open surgical)Procedure or surgery
Myomectomy (laparoscopic or open surgical)
| Study group | Role | What they receive |
|---|---|---|
| A Myomectomy | Active comparator | Removement of uterine fibroids by myomectomy Receives: 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) Receives: Procedure: Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 12 months after treatment
Secondary outcomes (12)
Hospital stay in days
Measured: 12 months after treatment
Pain according to visual analog scale
Visual analog scale ranges from 0-100, 0 indicating no pain, 100 severe pain
Measured: 12 months after treatment
Number of Adverse Events (AEs)
Measured: 12 months after treatment
Number of postinterventional/postsurgery treatment complications
Measured: 12 months after treatment
Number of re-interventions
Measured: 12 months after treatment
Alleviation of symptoms (irregular period, unfulfilled wish for child, pain, quality of life according to UFS-QoL
QoL: Quality of Life score regarding symptoms, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
Measured: 12 months after treatment
Health related quality of life according to UFS-QoL
QoL: Quality of Life score regarding health, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
Measured: 12 months after treatment
Sexuality related parameters according to UFS-QoL
QoL: Quality of Life score regarding sexuality, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
Measured: 12 months after treatment
Number of pregnancies and live births
Measured: 12 months after treatment
Number of late complications like venous thromboembolisms within Follow up time frame
Measured: 12 months after treatment
Number of fibroid recurrences (de novo fibroids) within Follow up time frame
Measured: 12 months after treatment
Time period until return to normal physical activities, measured by the rate of patients, who achieved an a priori clinically relevant reduction of SSS of UFS-QoL
at timepoints: months 1, 3 and 6 compared to baseline.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start15 Jul 2020
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thorsten O Götze, PD Dr. med., Principal investigator, Krankenhaus Nordwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948789
- Sponsor's protocol ID
- MARGI-T
- Status last verified
- Nov 2024
- First submitted
- 10 May 2019
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03948789
- Acronym / sponsor ID
- MARGI-T
- Conditions
- Uterine Fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Krankenhaus NordwestUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Myomectomy | Active comparator | Procedure: Myomectomy (laparoscopic or open surgical)Removement of uterine fibroids by myomectomy |
| B MRgFUS-TUF | Experimental | Procedure: Magnetic Resonance Imaging-controlled high-focussed ultrasound therapyRemovement of uterine fibroids by Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy (MRgFUS-TUF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging-controlled high-focussed ultrasound therapyMagnetic Resonance Imaging-controlled high-focussed ultrasound | Procedure or surgery | B MRgFUS-TUF |
| Myomectomy (laparoscopic or open surgical)Myomectomy (laparoscopic or open surgical) | Procedure or surgery | A Myomectomy |
Primary outcome
WAI question 4
Time frame: Until at least three consecutive days questionnaire was answered as indicated, up to 12 months
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).
Symptom Severity Score of the UFS-QoL
Time frame: 12 months after treatment
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 secondary outcomes
Hospital stay in days
Time frame: 12 months after treatment
Pain according to visual analog scale
Time frame: 12 months after treatment
Number of Adverse Events (AEs)
Time frame: 12 months after treatment
Number of postinterventional/postsurgery treatment complications
Time frame: 12 months after treatment
Number of re-interventions
Time frame: 12 months after treatment
Alleviation of symptoms (irregular period, unfulfilled wish for child, pain, quality of life according to UFS-QoL
Time frame: 12 months after treatment
Health related quality of life according to UFS-QoL
Time frame: 12 months after treatment
Sexuality related parameters according to UFS-QoL
Time frame: 12 months after treatment
Number of pregnancies and live births
Time frame: 12 months after treatment
Number of late complications like venous thromboembolisms within Follow up time frame
Time frame: 12 months after treatment
Number of fibroid recurrences (de novo fibroids) within Follow up time frame
Time frame: 12 months after treatment
Time period until return to normal physical activities, measured by the rate of patients, who achieved an a priori clinically relevant reduction of SSS of UFS-QoL
Time frame: 12 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten O Götze, PD Dr. med. principal investigator
Krankenhaus Nordwest
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myomectomy (laparoscopic or open surgical) in people with Uterine Fibroids, run by Krankenhaus Nordwest at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WAI question 4 (time frame: Until at least three consecutive days questionnaire was answered as indicated, up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.