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Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids

28 Years
Open (Enrolling)
Leiomyoma, Uterine Fibroids, Menorrhagia

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Trial Information

Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids

Inclusion Criteria:

- 28 years of age or older

- Consistent menstrual cycles

- History of excessive bleeding for at least 3 months

- Baseline UFS-QOL Symptom severity score ≥ 20

- At least one target fibroid having a maximum diameter > 5cm and ≤ 10 cm

- Not at material risk for pregnancy

- Willingness to participate, adhere to follow-up requirements, and sign the informed
consent form

- Willing to have uniform maintenance of antifibrinolytic or non steroidal
anti-inflammatory agents

Exclusion Criteria:

- Presence of type 0 intracavitary fibroids

- Target fibroid > 10cm in maximum diameter

- Abnormality of the endometrial cavity that obstructs access of the treatment device

- Postmenopausal

- Desire for current or future fertility

- Hemoglobin < 6 g/dl

- Evidence of disorders of hemostasis

- Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or
injectable progestin and/or estrogen, SERM or SPRM within the last 6 months prior to

- Evidence for current cervical dysplasia (CIN II or greater)

- Endometrial hyperplasia

- Confirmed abdominal / pelvic malignancy within previous five years

- Active pelvic infection or positive screen for pelvic gonorrhea or chlamydia

- Clinically significant adenomyosis

- Previous uterine artery embolization

- Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months
prior to screening

- Current use of anticoagulant therapy

- Major medical or psychiatric illness affecting general health or ability to adhere to

- Contraindication to MRI

- Renal insufficiency

- Uncontrolled hypertension lasting 2 years or more

- Calcified fibroids

- Presence of extrauterine pelvic mass

- Presence of tubal implant for sterilization

- Previous pelvic irradiation

- Endometrial cavity length < 4.5 cm

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean percentage change in target fibroid perfused volume

Outcome Time Frame:

Baseline, 3 months

Safety Issue:


Principal Investigator

David Toub, MD

Investigator Role:

Study Director

Investigator Affiliation:



United Kingdom: Research Ethics Committee

Study ID:

CL 03536



Start Date:

June 2012

Completion Date:

December 2013

Related Keywords:

  • Leiomyoma
  • Uterine Fibroids
  • Menorrhagia
  • uterine fibroid RF ablation
  • intrauterine ultrasound
  • VizAblate
  • Leiomyoma
  • Myofibroma
  • Menorrhagia