The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions) Study

Study Purpose and Objectives

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 Acessa System. Laparoscopic ultrasound (LUS) is a standard step prior to the Acessa procedure but has not been a standard step prior to LM. Incorporating LUS 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.

The primary objective of this study is to compare the mean time to discharge from the hospital following laparoscopic treatment of fibroids by either myomectomy or by Acessa. Secondary objectives are to compare multiple safety and efficacy outcome measures mainly complications, readmissions and reintervention rates, post op use of pain medication, recovery rates including return to work, post treatment changes in the severity of fibroid related symptoms including menstrual changes, post treatment changes in health-related quality of life and general health status, and overall patient satisfaction with the treatment.

This study is currently closed to enrollment and all subjects are in follow up.

Study Design

This is a post-market, randomized, prospective, single center, longitudinal, comparative study to evaluate the outcomes of GFA vs the current standard of care at a single center (laparoscopic myomectomy) for the treatment of symptomatic uterine fibroids in women who desire uterine conservation.

Fifty subjects recruited from referral centers within Germany have been treated. All subjects recruited consisted of women who desired uterine preservation and who were willing to be randomized. All study subjects will be expected to continue participation in the study for 60 months following treatment. The multiple endpoints of the clinical investigation will be assessed and reported at various intervals.

Study Endpoints

The primary and secondary endpoints are as follows:

Primary End Point:

  • Hospitalization time expressed as the number of hours from induction of anesthesia to discharge from the hospital.

Secondary Endpoints:

  • Intraoperative blood loss.
  • Incidence of post discharge readmission to hospital within 1month of procedure.
  • Days to return-to-work and return to normal activities of daily living.
  • Post procedure use of pain medication up to 3 months.
  • Rate of reintervention for fibroid-related symptoms up to 60 months post –procedure
  • Rate of procedure-related complications up to 60 months post-procedure.
  • Fibroid Symptom severity and quality of life at scores 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QOL) assessment tool.
  • General health outcome evaluation at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the EQ-5D (a standardized instrument for use as a measure of health outcome).
  • Menstrual Impact Score at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline.
  • Overall subject treatment outcome and satisfaction evaluation using the Overall Treatment Evaluation (OTE) at 3, 6, 12, 24, 36, 48, and 60 months post procedure.

For more information, please refer to www.clinicaltrials.gov where you will find a list of all ongoing studies using the Acessa System.

LI-00-0213-B