Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions (LUSTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01750008
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : June 11, 2018
Information provided by (Responsible Party):
Acessa Health, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Myomas Procedure: Global Fibroid Ablation Procedure: Myomectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study compares two laparoscopic interventions for the treatment of symptomatic uterine fibroids.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial
Study Start Date : November 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids

Arm Intervention/treatment
Global Fibroid Ablation
Global Fibroid Ablation
Procedure: Global Fibroid Ablation
Other Names:
  • Halt Procedure
  • Acessa Procedure

Laparoscopic Myomectomy
Myomectomy via laparoscopy
Procedure: Myomectomy

Primary Outcome Measures :
  1. 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 ]
    Capture and compare hospitalization time expressed as the number of hours from induction of anesthesia to discharge from hospital.

Secondary Outcome Measures :
  1. 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 incidence of post discharge readmission within 1 month of procedure and rate of reintervention for fibroid-related symptoms up to 60 months post procedure

  2. 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 intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment

  3. Compare and contrast recovery rate [ Time Frame: Discharge from hospital up to an average of 5 weeks post treatment ]
    Compare how many days it takes to return-to-work and to normal activities of daily living.

  4. 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 Baseline fibroid related symptoms to 3, 6, 12, 24, 36, 48 and 60 months post treatment

  5. Compare and contrast post-treatment patient satisfaction [ Time Frame: 3, 6, 12, 24, 36, 48, and 60 months post-treatment ]
    Compare the overall subject treatment outcome and satisfaction evaluation

  6. Compare and Contrast post-treatment changes in menstrual status. [ Time Frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment ]
    Compare Baseline menstrual impact to 3, 6, 12, 24, 36, 48 and 60 months post treatment.

  7. 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 ]
    Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01750008

Tubingen University Hospital
Tubingen, Germany, 72074
Sponsors and Collaborators
Acessa Health, Inc.
Principal Investigator: Sara Brucker, MD University of Tubingen

Publications of Results:
Other Publications:
Levine DJ, Harris M, Berman JM, Macer J, Abbott K, Lee BB. Leiomyoma assessment by intra-abdominal ultrasound compared to preoperative ultrasound and preoperative magnetic imaging. J Minim Invasive Gynecol. 2011;18(suppl):S1.
U.S. Valuation of the EuroQoL EQ-5D Health States. December 2005. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gove/rice/EQ5Dproj.htm

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Acessa Health, Inc. Identifier: NCT01750008     History of Changes
Other Study ID Numbers: CP-00-0018
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2017

Keywords provided by Acessa Health, Inc.:
Symptomatic Uterine Fibroids
Heavy Bleeding
Radiofrequency Ablation

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases