Back to resultsLaparoscopic Uterine Sparing Techniques Outcomes and Reinterventions (LUSTOR)
Primary Purpose
Uterine Fibroids, Myomas
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Global Fibroid Ablation
Myomectomy
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring Symptomatic Uterine Fibroids, Menorrhagia, Heavy Bleeding, Myomas, Radiofrequency Ablation, RFA, Leiomyoma, Fibroids
Eligibility 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.
Sites / Locations
- Tubingen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Global Fibroid Ablation
Laparoscopic Myomectomy
Arm Description
Global Fibroid Ablation
Myomectomy via laparoscopy
Outcomes
Primary Outcome Measures
Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA
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
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
Compare intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment
Compare and contrast recovery rate
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.
Compare Baseline fibroid related symptoms to 3, 6, 12, 24, 36, 48 and 60 months post treatment
Compare and contrast post-treatment patient satisfaction
Compare the overall subject treatment outcome and satisfaction evaluation
Compare and Contrast post-treatment changes in menstrual status.
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.
Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
Full Information
NCT ID
NCT01750008
First Posted
December 11, 2012
Last Updated
November 16, 2018
Sponsor
Acessa Health, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01750008
Brief Title
Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions
Acronym
LUSTOR
Official Title
The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acessa Health, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Myomas
Keywords
Symptomatic Uterine Fibroids, Menorrhagia, Heavy Bleeding, Myomas, Radiofrequency Ablation, RFA, Leiomyoma, Fibroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study compares two laparoscopic interventions for the treatment of symptomatic uterine fibroids.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Global Fibroid Ablation
Arm Type
Other
Arm Description
Global Fibroid Ablation
Arm Title
Laparoscopic Myomectomy
Arm Type
Other
Arm Description
Myomectomy via laparoscopy
Intervention Type
Procedure
Intervention Name(s)
Global Fibroid Ablation
Other Intervention Name(s)
Halt Procedure, Acessa Procedure
Intervention Type
Procedure
Intervention Name(s)
Myomectomy
Primary Outcome Measure Information:
Title
Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA
Description
Capture and compare hospitalization time expressed as the number of hours from induction of anesthesia to discharge from hospital.
Time Frame
From admission to the duration of hospital stay, an expected average of 3 days
Secondary Outcome Measure Information:
Title
Compare and contrast post-treatment readmission and reintervention rate
Description
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
Time Frame
Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment
Title
Compare and Contrast peri and post procedural safety including procedural blood loss and complications
Description
Compare intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment
Time Frame
Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Title
Compare and contrast recovery rate
Description
Compare how many days it takes to return-to-work and to normal activities of daily living.
Time Frame
Discharge from hospital up to an average of 5 weeks post treatment
Title
Compare and Contrast post-treatment changes in fibroid symptom severity.
Description
Compare Baseline fibroid related symptoms to 3, 6, 12, 24, 36, 48 and 60 months post treatment
Time Frame
Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Title
Compare and contrast post-treatment patient satisfaction
Description
Compare the overall subject treatment outcome and satisfaction evaluation
Time Frame
3, 6, 12, 24, 36, 48, and 60 months post-treatment
Title
Compare and Contrast post-treatment changes in menstrual status.
Description
Compare Baseline menstrual impact to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
Time Frame
Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
Title
Compare and Contrast post-treatment changes concerning health-related quality-of-life.
Description
Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
Time Frame
Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Brucker, MD
Organizational Affiliation
University of Tubingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tubingen University Hospital
City
Tubingen
ZIP/Postal Code
72074
Country
Germany
12. IPD Sharing Statement
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Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions
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