Overview

This trial is active, not recruiting.

Conditions uterine fibroids, myomas
Treatments global fibroid ablation, myomectomy
Phase phase 4
Sponsor Halt Medical, Inc
Start date November 2012
End date September 2013
Trial size 50 participants
Trial identifier NCT01750008, CP-00-0018

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Other)
Global Fibroid Ablation
global fibroid ablation Halt Procedure
(Other)
Myomectomy via laparoscopy
myomectomy

Primary Outcomes

Measure
Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA
time frame: From admission to the duration of hospital stay, an expected average of 3 days

Secondary Outcomes

Measure
Compare and contrast post-treatment readmission and reintervention rate
time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment
Compare and Contrast peri and post procedural safety including procedural blood loss and complications
time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and contrast recovery rate
time frame: Discharge from hospital up to an average of 5 weeks post treatment
Compare and Contrast post-treatment changes in fibroid symptom severity.
time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and contrast post-treatment patient satisfaction
time frame: 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and Contrast post-treatment changes in menstrual status.
time frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
Compare and Contrast post-treatment changes concerning health-related quality-of-life.
time frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment

Eligibility Criteria

Female participants from 18 years up to 55 years old.

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.

Additional Information

Official title The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial
Principal investigator Sara Brucker, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Halt Medical, Inc.