Myomas, Uterine Fibroids
Conditions
Keywords
Symptomatic Uterine Fibroids, Menorrhagia, Heavy Bleeding, Myomas, Radiofrequency Ablation, RFA, Leiomyoma, Fibroids
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.
Interventions
PROCEDUREGlobal Fibroid Ablation
PROCEDUREMyomectomy
Sponsors
Acessa Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Study compares two laparoscopic interventions for the treatment of symptomatic uterine fibroids.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA | 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
| Measure | Time frame | Description |
|---|---|---|
| Compare and Contrast peri and post procedural safety including procedural blood loss and complications | 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 |
| Compare and contrast recovery rate | 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. |
| Compare and Contrast post-treatment changes in fibroid symptom severity. | 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 |
| Compare and contrast post-treatment readmission and reintervention rate | 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 |
| Compare and Contrast post-treatment changes in menstrual status. | 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. |
| Compare and Contrast post-treatment changes concerning health-related quality-of-life. | 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. |
| Compare and contrast post-treatment patient satisfaction | 3, 6, 12, 24, 36, 48, and 60 months post-treatment | Compare the overall subject treatment outcome and satisfaction evaluation |
Countries
Germany
Outcome results
None listed