Post Market TRUST - U.S.A. Study

Acessa Health

Status: Active, not recruiting

Conditions: Symptomatic Uterine Fibroids

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02163525

CP-00-0025

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. In addition, data from this study is being used to satisfy the requirements of the United States Food and Drug Administration's 522 (post market surveillance) order.

Full description

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.

Enrollment: 114 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Ablation vs Embolization

Active Comparator group

Description:

Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)

Treatment:

Procedure: Global Fibroid Ablation (GFA)

Procedure: Uterine Artery Embolization (UAE)

Ablation vs Myomectomy

Active Comparator group

Description:

Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)

Treatment:

Procedure: Global Fibroid Ablation (GFA)

Procedure: Abdominal or Laparoscopic Myomectomy