General Information

Age Group

Adults

Status

Active, not recruiting

Protocol Number

NCT02163525

Background Information

Fibroids are growths that are non-cancerous tumors of the uterus (womb). Fibroids can cause heavy bleeding, belly pain, pressure, frequent urination, and other problems. Fibroids are most often discovered through a pelvic examination, which may reveal a lumpy or enlarged uterus. In patients with heavy monthly bleeding, physicians may perform an ultrasound examination (a picture formed using sound waves) to see the uterus and detect fibroids.

A company called Acessa Health, Inc. has developed a method for the treatment of fibroids. This method is called Global Fibroid Ablation (GFA). GFA uses radiofrequency energy to treat the fibroid utilizing a special treatment probe. Radiofrequency energy causes the fibroid to heat up. While performing GFA, your doctor will use ultrasound to find fibroids you may have.

The purpose of this study is to compare the outcomes, including costs, of this new procedure, compared to other standard procedures that are also currently used to treat fibroids. Your doctor will collect information regarding your recovery, your satisfaction with the procedure you have received, including cost information, and safety data.

Offered At

3300 Gallows Rd.
Falls Church, Virginia 22042

500 N Washington St #300
Falls Church, Virginia 22046 
Principal Investigator

Seyed Shobeiri, MD

Eligibility Information

  • ≥ 18 years old and menstruating.
  • You have symptomatic uterine fibroids.
  • Have had a normal Pap smear within the past 36 months.
  • Are capable of providing informed consent.

Ineligibility Information

Women who:

  • Are pregnant.
  • Have chronic pelvic pain known to not be due to uterine fibroids.
  • Have active or history of pelvic inflammatory disease.
  • Have had pelvic radiation.
  • Are not willing to be randomized to treatment.