Post Market TRUST - U.S.A. Study

The purpose of this study is to 1) evaluate the economic burden, safety and outcomes of three
uterine-conserving treatment alternatives for symptomatic uterine fibroids: myomectomy,
uterine artery embolization (UAE), and global fibroid ablation (GFA) using the Acessa™
System, and 2) meet the requirements of the U.S. Food and Drug Administration's 522 Order for
post market surveillance In this study, subjects who have symptomatic uterine fibroids will
be randomized to one of three uterine-conserving treatments based on the local standard of
care.

Inclusion Criteria:

- Are ≥ 18 years old and menstruating

- Have symptomatic uterine fibroids

- Have a uterine size ≤ 16 gestational weeks as determined by pelvic exam

- Have all fibroids that are less than 10 cm in any diameter

- Desire uterine conservation

- Have had a normal Pap smear within the past 36 months defined as "no untreated
cervical malignancy or dysplasia."

- Are willing and able to comply with all study tests, procedures, and assessment tools

- Are capable of providing informed consent.

Exclusion Criteria:

- Have contraindications for laparoscopic surgery and/or general anesthesia.

- Are expected to be high risk for, or are known to have, significant intra-abdominal
adhesions (defined as adhesions that would require extensive dissection to mobilize
and view all surfaces of the uterus)

- Patients requiring major elective concomitant procedures (e.g., hernia repair)

- Are pregnant or lactating

- Have taken any depot gonadotropin releasing hormone (GnRh) agonist within three months
prior to the screening procedures

- Have an implanted intrauterine or fallopian tube device for contraception that cannot
or will not be removed at least 10 days prior to treatment

- Have chronic pelvic pain known to not be due to uterine fibroids

- Have known or suspected endometriosis Stage 3 or 4, adenomyosis

- Have active or history of pelvic inflammatory disease

- Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the
past five years

- Have had pelvic radiation

- Have a non-uterine pelvic mass over 3 cm

- Have a cervical myoma

- Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1
submucous fibroids that are better treated via hysteroscopic methods

- In the medical judgment of the investigator should not participate in the study

- Are not willing to be randomized to treatment.