Trial document





This trial has been registered retrospectively.
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  DRKS00020529

Trial Description

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Title

Use of the mobile HIFU device (high-intensity focused ultrasound) for treatment of patients with uterine fibroids

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Trial Acronym

HIFU-MH19

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URL of the Trial

http:///

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Brief Summary in Lay Language

The aim of the present study is to investigate the safety and effectiveness of local therapy with HIFU in patients with uterine myomatosus using a specially designed mobile device.

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Brief Summary in Scientific Language

The aim of the present study is to investigate the safety and effectiveness of local therapy with HIFU in patients with uterine myomatosus using a specially designed mobile device.
Prospective, GCP-compliant studies of the extent to which local tumor control or a clinically relevant improvement in fibroid-associated symptoms can be achieved in these patients (e.g. pain, bleeding intensity, functional status, quality of life) have so far not been available in Europe.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

the staff is currently missing to handle additional tasks

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Organizational Data

  •   DRKS00020529
  •   2020/01/30
  •   [---]*
  •   yes
  •   Approved
  •   295/19, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   D25.1 -  Intramural leiomyoma of uterus
  •   N80.0 -  Endometriosis of uterus
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Interventions/Observational Groups

  •   It is a treatment with the mobile ultrasound-guided HIFU System 1 of Mirabilis. The device is CE-marked for the treatment of uterine fibroids.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The main purpose of this clinical study is to evaluate prospectively and standardizedly the effectiveness and safety of local therapy with high-intensity focused ultrasound (HIFU) using a mobile device in patients with uterine fibroids.

The expected total duration of the study is 30 months.
• The study duration for the study patient is a total of 7 months (including 1 month between presentation and treatment)
• Duration of treatment: 2-4 hours, intervention itself expected <1 hour
• Observation phase after the procedure: 6 months


The primary evaluation is based on the size reduction of the fibroids by determining the fibroid volume over time.
• Comparison of the absolute fibroid volume (in ml) and the percentage change (expected reduction) over time: 3 months and 6 months after HIFU treatment compared to the corresponding baseline values.

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Secondary Outcome

• Recording therapy-associated side effects
• Recording the intervention parameters of the HIFU treatment
• Evaluation of changes in fibroid-related symptoms and health-related quality of life

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/09/17
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Age ≥ 18 years
• Signed informed consent consent for treatment and study participation
• Patients who are able to follow the study instructions and ikely to comply with all necessary study visits (compliance)
• Uterine fibroids (at least one fibroid ≥ 2 cm)
• The fibroids can be sufficiently visualized and safely treated with the mobile HIFU device using ultrasound
• Negative pregnancy test (ß-HCG test in serum)
• MRI compatibility

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Exclusion Criteria

• Present pregnancy or breastfeeding
• Suspected malignancy of the uterus, including an abnormal cancer smear
• Acute cystitis
• Acute infection that according to the study doctor or anesthetist makes it impossible to perform the treatment (e.g. severe cold, pneumonia, bronchitis)
• Fibroids cannot be adequately visualized with the mobile HIFU device, as they e.g. lie too far posterior or are covered by intestinal gas
• Pedunculated fibroids
• Subserous fibroids, fibroids in the posterior uterine wall
• Fibroids smaller than 2 cm (method-specific)
• Extended scarring in the acoustic pathway e.g. after previous surgery
• Ileal conduit
• No painkillers or analgetics can be administered
• Known or ongoing abuse of medication, drugs or alcohol
• Simultaneous participation in another clinical trial with taking an investigational medicinal product up to 30 days before participating in this clinical trial or using a medical device, which may influence the study carried out here

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Addresses

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    • Klinik für Diagnostische und Interventionelle Radiologie, Universitätskliniken Bonn
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    •   022828715870
    •   [---]*
    •   [---]*
    •   [---]*
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    • Klinik für Diagnostische und Interventionelle Radiologie, Universitätskliniken Bonn
    • Ms.  Priv.-Doz. Dr. Dr.  Milka  Marinova 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Klinik für Diagnostische und Interventionelle Radiologie, Universitätskliniken Bonn Abteilung HIFU/Innere Medizin
    • Ms.  Priv.-Doz. Dr. Dr.   Milka  Marinova 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Diagnostische und Interventionelle Radiologie, Universitätskliniken Bonn
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.