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Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores


N/A
25 Years
N/A
Not Enrolling
Female
Leiomyoma, Uterine Fibroids, Menorrhagia

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Trial Information

Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores


Inclusion Criteria:



- Pre-menopausal

- Regular, consistent menstrual cycles

- Serum progesterone > 6 ng/ml (19 nmol/L)

- 2 months history of PBLAC score of 150-500

- Maximum of 4 type I, type II, or intramural fibroids

- Patient is at low risk for cervical cancer

- Hemoglobin > 6 g/dl

- Not at risk for pregnancy

- No desire for future fertility

- Willing and able to complete the follow-up requirements outlined in the study design
section of the protocol

- Willing to sign a consent form

Exclusion Criteria:

- Subserosal fibroids.

- Any fibroid that obstructs access to the endometrial cavity

- FSH > 20 IU/L

- Pregnancy

- Evidence of disorders of hemostasis

- Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or
injectable progestin and/or estrogen

- SERMS/SPRMS within the last 6 months

- Current use of any IUD or use of Mirena IUS within the last 3 months

- Gynecological malignancy or hyperplasia

- Known/suspected abdominal/pelvic cancer

- Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory
disease)

- Adenomyosis

- Previous surgical or ablative treatment for fibroids or menorrhagia

- Previous uterine artery embolization or occlusion

- Patient on anti-coagulation therapy

- Needing emergency surgery to treat fibroid symptoms

- Concomitant intrauterine polyps.

- Major medical or psychiatric illness affecting general health or patient's ability to
comply with follow-up schedule or provide valid patient self-assessment data

- Contraindication to MRI

- Allergy to contrast media

- Mild renal insufficiency or worse

- Known renal disease

- Uncontrolled hypertension lasting 2 years or more

- Diabetes

- Uterine size > 10 weeks or 10 cm from ectocervix to fundus.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)

Outcome Time Frame:

Baseline, 3 mo, 6 mo, 9 mo, 12 mo

Safety Issue:

No

Principal Investigator

David Toub, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gynesonics

Authority:

Canada: Health Canada

Study ID:

CL00635

NCT ID:

NCT00768742

Start Date:

September 2008

Completion Date:

September 2011

Related Keywords:

  • Leiomyoma
  • Uterine Fibroids
  • Menorrhagia
  • Uterine Fibroid RF Ablation
  • Intrauterine Ultrasound
  • VizAblate
  • Leiomyoma
  • Myofibroma
  • Menorrhagia

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