Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions (LUSTOR)

Acessa Health

Status

Completed

Conditions

Uterine Fibroids

Myomas

Treatments

Procedure: Myomectomy

Procedure: Global Fibroid Ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01750008

CP-00-0018

Details and patient eligibility

About

The purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have equal access to valuable imaging information and to plan treatment accordingly. By randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one treatment or the other following the LUS is eliminated.

Enrollment

51 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts 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 fibroids that are less than 10 cm in any diameter
Desire uterine conservation
Have had a normal Papanicolaou test (PAP smear) (i.e. PAP I or PAP II) at the latest pre-study examination and no longer than 36 months before study entry.
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, hysteroscopic resection, endometrial ablation, uterine artery ligation, etc.) that could confound the results of the study
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 ten days prior to treatment
Have chronic pelvic pain not due to uterine fibroids
Have known or suspected endometriosis or 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.