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Uterine Leiomyoma Treatment With Radiofrequency Ablation


Phase 4
21 Years
N/A
Not Enrolling
Female
Uterine Fibroids

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Trial Information

Uterine Leiomyoma Treatment With Radiofrequency Ablation

Inclusion Criteria


INCLUSION CRITERIA

1. Premenopausal (at least 1 menstrual period in last 3 months)

2. Age >21years

3. Fibroids are associated with heavy bleeding, pelvic pressure or discomfort, urinary
or bowel symptoms, or dyspareunia

4. Desires surgical management of fibroids

5. Uterus <16 weeks in size

6. All fibroids <10cm in maximum diameter by ultrasound or MRI assessment

7. Total number of fibroids <6 by ultrasound or MRI assessment

8. Had a Pap smear within the last 3 years with appropriate follow-up and treatment for
cellular abnormalities

9. Endometrial biopsy indicates no hyperplasia or cancer (biopsy only required if age
>45 years and has anovulatory heavy bleeding)

10. Able to tolerate laparoscopic surgery

11. Able to give informed consent

EXCLUSION CRITERIA

1. Planned treatment for infertility

2. Pedunculated fibroid with thin stalk (total stalk length is <50% maximum diameter of
fibroid)

3. All symptomatic fibroids are intracavitary (FIGO Type 0) or submucosal with >50% of
fibroid within endometrial cavity (FIGO Type 1)

4. Planned concomitant surgical procedure in addition to treatment of uterine fibroids

5. Use of Essure or any other metallic, implantable device within pelvis

6. Pregnancy

7. Pelvic infection with the last 3 months

8. History of pelvic malignancy and/or pelvic radiation

9. Known or high suspicion for dense pelvic adhesions

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Changes in fibroid-related symptoms after the Acessa procedure.

Outcome Description:

We will use standard questionnaires for women with fibroids to assess changes in fibroid symptoms including menstrual pattern and flow and overall quality of life.

Outcome Time Frame:

Baseline to 3 years.

Safety Issue:

No

Principal Investigator

Vanessa Jacoby, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

13-11026

NCT ID:

NCT01840124

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Uterine Fibroids
  • Fibroids
  • Radiofrequency ablation
  • Leiomyoma
  • Myofibroma

Name

Location

University of California, San FranciscoSan Francisco, California  94143