Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions (LUSTOR)

November 16, 2018 updated by: Acessa Health, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tubingen, Germany, 72074
        • Tubingen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Global Fibroid Ablation
Procedure: Global Fibroid Ablation
Other Names:
  • Halt Procedure
  • Acessa Procedure
Other: Laparoscopic Myomectomy
Myomectomy via laparoscopy
Procedure: Myomectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From admission to the duration of hospital stay, an expected average of 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment
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 how many days it takes to return-to-work and to normal activities of daily living.
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 Baseline fibroid related symptoms to 3, 6, 12, 24, 36, 48 and 60 months post treatment
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 the overall subject treatment outcome and satisfaction evaluation
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 Baseline menstrual impact to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
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
Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acessa Health, Inc.

Investigators

  • Principal Investigator: Sara Brucker, MD, University of Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-00-0018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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