About ULTRA

 

What is ULTRA?

ULTRA is a study for women who are planning to undergo radiofrequency ablation (AcessaTM) to treat uterine fibroids.

What happens if I participate in ULTRA?

Participants in the ULTRA study:

  • Complete questionnaires online or by mail about reproductive health and fibroid-related symptoms
  • Receive up to $50 for participation

What is the purpose of ULTRA?

The device used to perform radiofrequency ablation (AcessaTM) is a new treatment for women with fibroids. The goal of ULTRA is to understand how this treatment:

  • Changes fibroid symptoms
  • Affects fertility and pregnancy
  • Impacts the need for additional fibroid treatment in the future

Why should I join ULTRA?

Hearing from women who undergo radiofrequency ablation (AcessaTM) is the best way to understand how treatment impacts fibroid symptoms and reproductive health. The information collected from the questionnaires you complete will be used to better inform women with fibroids about what to expect after treatment with radiofrequency ablation (AcessaTM).

Can I participate in ULTRA?

The ULTRA Registry is a nationwide study open to all women age 21 years or older who plan to undergo laparoscopic radiofrequency ablation (AcessaTM) for the treatment of uterine fibroids. The ULTRA Registry is not currently enrolling. Please contact us to be notified when the study reopens.

The ULTRA Trial is a study of women undergoing laparoscopic radiofrequency ablation (AcessaTM) at one of the 5 University of California hospitals: UC San Francisco, UC Davis, UC Los Angeles, UC Irvine, and UC San Diego. The ULTRA Trial is closed to recruitment.

What is radiofrequency ablation (AcessaTM) of fibroids?

Radiofrequency ablation (Acessa™) of fibroids uses heat to destroy the fibroid tissue. Radiofrequency ablation (Acessa™) is performed during a laparoscopic surgery. A small 5 mm incision is made in the belly button. A thin lighted telescope is placed through this incision to visualize the uterus and surrounding organs. A 1 cm incision is made in the skin overlying the uterus. A special ultrasound probe that works inside the body is placed on the uterus to clearly see the fibroids. A long needle-like device is inserted into the fibroid.  Once the needle is in the middle of the fibroid, the energy is activated and heat is delivered directly to the fibroid until the entire fibroid is destroyed. The treated fibroid shrinks in size by 40-50% within 3 months after treatment.

What is the recovery time after radiofrequency ablation (Acessa™) of fibroids?

Radiofrequency ablation (Acessa™) is an outpatient surgery.  You can go home several hours after the surgery. Most women are able to return to their normal activities in 5-9 days.

How is radiofrequency ablation (Acessa™) of fibroids different than Myomectomy?

Radiofrequency ablation (Acessa™) is an operation to heat fibroids to the point of destroying the tissue.  The fibroids remain inside the uterus but shrink in size. Myomectomy is an operation in which fibroids are removed from the uterus.

What are the different fibroid treatment options?

Treatments for fibroids include close monitoring, medical therapy, myomectomy, hysterectomy, radiofrequency ablation (AcessaTM), uterine artery embolization, and MR guided focused ultrasound. Click on each option to read more on the UCSF Comprehensive Fibroid Center website. 
 •   Close monitoring
 •   Medical therapy
 •   Myomectomy
 •   Hysterectomy
 •   Radiofrequency ablation (AcessaTM)
 •   Uterine Artery Embolization
 •   MR Guided Focused Ultrasound

Who can participate in the ULTRA Registry?

The ULTRA Registry is open to all women age 21 years or older who plan to undergo laparoscopic radiofrequency ablation (Acessa™) for treatment of fibroids. The ULTRA Registry is not currently enrolling. Please contact us to be notified when the study reopens.

Will I be paid for participating in the ULTRA registry?

If you are eligible and enroll in ULTRA, you will be paid up to $50 in debit or gift cards for taking part in this study. Before surgery and at 6, 12, 24, and 36 months you will receive $10 in debit or gift cards for completing questionnaires about your health and fibroid symptoms.
Please note, the cost of the procedure is NOT covered by the ULTRA study.

Where can I enroll?

The ULTRA Registry is being conducted at many sites. Click on the map below to find a site.

How many patients are in the ULTRA Registry?

Approximately 100 women will be enrolled in the ULTRA Registry.