Know Cancer

forgot password

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

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

Thank you

Trial Information

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

Inclusion Criteria:

- 28 years of age or older

- Regular, consistent menstrual cycles

- Objective evidence of normal ovulatory function

- History of excessive bleeding

- One Menstrual Pictogram score ≥ 120 during a one-month screening period

- Baseline Uterine Fibroid Symptom & Quality of Life (UFS-QOL) Symptom Severity
Subscale (SSS) score ≥ 20

- Between 1 and 5 Target Fibroids between 1 cm and 5 cm

- At least one fibroid must indent the endometrium

- Subject is not at material risk for pregnancy.

- Subject is willing to maintain use or non-use of hormonal contraception

- Subject is willing to have uniform maintenance (use or non-use) of any
antifibrinolytic or nonsteroidal anti-inflammatory agents

Exclusion Criteria:

- Subserosal fibroids with bulk symptoms

- Presence of type 0 intracavitary fibroids

- Any Target Fibroid > 5 cm in maximum diameter

- Any fibroid that obstructs access of the VizAblate probe

- Postmenopausal by history

- Desire for current or future fertility

- Hemoglobin < 6 g/dl

- Pregnancy

- Evidence of disorders of hemostasis

- Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable
progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective
progesterone receptor modulator (SPRM)

- Current use of any intrauterine device (IUD) or use of Mirena® intrauterine system

- Use of hormonal medication for management of bleeding

- Evidence for current cervical dysplasia

- Endometrial hyperplasia

- Confirmed abdominal / pelvic malignancy within the previous five years

- Active pelvic infection

- Clinically significant adenomyosis

- Previous surgical, embolizational, or ablative treatment for fibroids or menorrhagia

- Current use of anticoagulant therapy

- Need for emergency surgery to treat fibroid symptoms

- Concomitant intrauterine polyps > 1.0 cm

- Contraindication to MRI

- Renal insufficiency

- Uncontrolled hypertension lasting 2 years or more

- Uterine size > 12 weeks

- One or more treatable fibroids that are calcified

- Chronic pelvic pain

- Presence of an extrauterine pelvic mass

- Presence of a tubal implant for sterilization

- Previous pelvic irradiation

- Endometrial cavity length < 4.5 cm

Type of Study:


Study Design:

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, at procedure, 3 months

Safety Issue:


Principal Investigator

David Toub, MD

Investigator Role:

Study Director

Investigator Affiliation:



Mexico: Federal Commission for Sanitary Risks Protection

Study ID:




Start Date:

January 2011

Completion Date:

November 2013

Related Keywords:

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