Post Market TRUST Study

Acessa Health

Status: Completed

Conditions: Uterine Fibroids

Treatments: Procedure: Uterine Artery Embolization (UAE); Procedure: Global Fibroid Ablation (GFA); Procedure: Abdominal or Laparoscopic Myomectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563783

CP-00-0015

Details and patient eligibility

About

This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.

Full description

Uterine fibroids are the most common pelvic neoplasms in women; they severely impact quality of life and are the leading indication for hysterectomy. Hysterectomy is the definitive treatment for myomas; however, many patients seek alternative uterine-sparing therapy and desire to conserve their fertility. Myomectomy is a much-reported surgical option for women with symptomatic fibroids and, until recently, the abdominal approach has been the approach of choice for most surgeons. Over time, patients have requested less invasive procedures and minimally invasive, laparoscopic options are becoming more popular among patients and their gynecologists. Standard surgical and interventional treatments for uterine fibroids are costly to society and to the health care system. New technologies such as GFA may offer a low-cost alternative to the standard treatments for symptomatic uterine fibroids in women who desire uterine conservation. This study seeks to evaluate those cost differences between three available uterine-sparing techniques and to explore the qualitative outcomes such as symptom severity, health related quality of life, and overall treatment effect.

Enrollment: 84 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

84 participants in 2 patient groups

Woman Suitable for Myomectomy or GFA

Active Comparator group

Description:

This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or Myomectomy (laparoscopic or abdominal).

Treatment:

Procedure: Abdominal or Laparoscopic Myomectomy

Procedure: Global Fibroid Ablation (GFA)

Woman Suitable for UAE or GFA

Active Comparator group

Description:

This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or uterine artery embolization (UAE).

Treatment:

Procedure: Global Fibroid Ablation (GFA)

Procedure: Uterine Artery Embolization (UAE)