Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions (Lustor)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Halt Medical, Inc
ClinicalTrials.gov Identifier:
NCT01750008
First received: December 11, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Uterine Fibroids
Myomas
Procedure: Global Fibroid Ablation
Procedure: Myomectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial

Resource links provided by NLM:


Further study details as provided by Halt Medical, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Capture and compare hospitalization time expressed as the number of hours from induction of anesthesia to discharge from hospital.


Secondary Outcome Measures:
  • Compare and contrast post-treatment readmission and reintervention rate [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: Yes ]
    Compare intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment

  • Compare and contrast recovery rate [ Time Frame: Discharge from hospital up to an average of 5 weeks post treatment ] [ Designated as safety issue: No ]
    Compare how many days it takes to return-to-work and to normal activities of daily living.

  • 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 ] [ Designated as safety issue: No ]
    Compare Baseline fibroid related symptoms to 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 ] [ Designated as safety issue: No ]
    Compare the overall subject treatment outcome and satisfaction evaluation

  • Compare and Contrast post-treatment changes in menstrual status. [ Time Frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment ] [ Designated as safety issue: No ]
    Compare Baseline menstrual impact to 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 ] [ Designated as safety issue: No ]
    Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Global Fibroid Ablation
Global Fibroid Ablation
Procedure: Global Fibroid Ablation
Other Names:
  • Halt Procedure
  • Acessa Procedure
Laparoscopic Myomectomy
Myomectomy via laparoscopy
Procedure: Myomectomy

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750008

Locations
Germany
Tubingen University Hospital
Tubingen, Germany, 72074
Sponsors and Collaborators
Halt Medical, Inc
Investigators
Principal Investigator: Sara Brucker, MD University of Tubingen
  More Information

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.

Responsible Party: Halt Medical, Inc
ClinicalTrials.gov Identifier: NCT01750008     History of Changes
Other Study ID Numbers: CP-00-0018
Study First Received: December 11, 2012
Last Updated: February 24, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Halt Medical, Inc:
Symptomatic Uterine Fibroids
Menorrhagia
Heavy Bleeding
Myomas
Radiofrequency Ablation
RFA
Leiomyoma
Fibroids

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

ClinicalTrials.gov processed this record on April 17, 2014