Halt Medical, Inc. believes in the importance of patient-centered outcomes research and the continued study of uterine-conserving procedures. To offer patients the best treatment alternatives, clinicians need to 1) be aware of all treatment alternatives, and 2) be provided with adequate safety, efficacy and cost data. To achieve this, Halt Medical is listing several post-market studies that compare available uterine-conserving procedures that are considered the standard of care within the gynecology community.

Providing gynecologists with these data in turn allows them to adequately inform their patients of the risks, benefits and costs of the various treatment alternatives for symptomatic uterine fibroids. We invite you to read a brief description on each of the post-market studies using the Acessa System. You may also refer to www.clinicaltrials.gov for further information on the Halt Medical studies.

Clinical Studies and Associated Publications

Clinical studies have been conducted and published regarding the safety, effectiveness and durability of the Acessa™ procedure for the treatment of uterine fibroids. The results from these trials consistently show that the Acessa outpatient procedure results in a reduction in uterine size, significantly reduced menstrual bleeding, significantly decreased symptom severity and a significantly improved quality of life. The following are descriptions of the clinical trial publications to date:

Trials of the Acessa System

Berman, et al described the 3-year follow up results of the study previously reported by Chudnoff et al (1-year results) and Guido et al (2-year results). In this report, 107 of the 135 treated subjects’ data were available at 3 years. Published in The Journal of Minimally Invasive Gynecology (JMIG) Berman JM, Guido RS, Leal JGG, Pemueller RR, Whaley FS, Chudnoff SG, Three Years’ Outcome from the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas 2014;21(5):767-774.

Findings:

  • Mean scores representing reduction in symptom severity, improvement in health-related quality of life and improvement in general health state were maintained.

Guido, et al, discussed long-term outcomes of the 124 women who were followed for two years in the previously reported by Chudnoff et al. Published in Health and Quality of Life Outcomes; “Radiofrequency Volumetric Thermal Ablation of Symptomatic Fibroids: Two Years’ Outcome from the Halt Trial.”

Findings:

  • The authors described the sustained decrease in symptom severity, the improvement in health-related quality of life and the low re-intervention rate at 2 years post-treatment.

Chudnoff, et al, wrote “Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas,” which was published online by Obstetrics and Gynecology in November 2012 and in print in May 2013. The study was 12-month outcomes for the 135 women who were highly symptomatic and were treated with the Acessa System.

Findings:

  • Results showed meaningful reduction in menstrual blood loss along with a 25% reduction in uterine volume and 44% reduction in fibroid volume by 12 months post-treatment.
  • Significant patient quality-of-life improvements, significant decrease in symptom severity and menstrual blood loss, a low device-related adverse event rate and only one re-intervention lead the authors to conclude that treatment of fibroids with radiofrequency ablation (Acessa) may play a significant role in the future of fibroid management.

Brucker, et al, introduced the first randomized, prospective study of 50 patients who received laparoscopic fibroid treatment with either Acessa or myomectomy. This paper entitled,“Initial Results from a Randomized Controlled Study of Laparoscopic Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy” is available in the International Journal of Gynecology and Obstetrics.

Findings:

  • In the immediate post-operative phase, mean hospitalization times were found to be nearly 3x longer in the laparoscopic myomectomy group. Intraoperative blood loss was also significantly greater in the myomectomy group.

Galen, et al, analyzed the data from the trial of 135 women, specifically the effect of intramural fibroids on menorrhagia. This article entitled “Does Menstrual Bleeding Decrease After Ablation of Intramural Myomas? A Retrospective Study” was published in the Journal of Minimally Invasive Gynecology.

Findings:

  • Acessa resulted in a clinically and statistically significant reduction in menstrual blood loss.

Levine et al describes the benefits of using laparoscopic ultrasound in “Sensitivity of Myoma Imaging Using Laparoscopic Ultrasound Compared With Magnetic Resonance Imaging and Transvaginal Ultrasound.”

Findings:

  • Acessa treatment was twice as effective in detecting myomas compared to transvaginal ultrasound and also superior to contrast-enhanced magnetic resonance imaging.

Galen, et al, published an article comparing the feasibility study results with the 1-year results from the international trial. This manuscript entitled “Laparoscopic Radiofrequency Ablation of Fibroids: Phase II / Phase III Results” has been accepted by the Journal of the Society of Laparoendoscopic Surgeons and will be available to subscribers in Vol. 18, Number 2 (Apr/May/Jun 2014 Issue).

Findings:

  • All studies (total 206 subjects) showed a post-treatment median of 4-5 days to return to work, significant reduction in uterine volume and significant improvements to symptoms, health and quality of life.

Macer published a November 2013 article in OBG Management entitled “For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation: Profile of a new minimally invasive treatment option.” Dr. Macer refers to the previously published results on RFA prior to Acessa and after Acessa was introduced as a new treatment option for symptomatic fibroids. He not only describes the technique in detail, but weaves in an interesting case study within the article. The full article is available in OBG Management November 2013 | Vol. 25, No. 11: 50-55.

The TRUST (Treatment Results of Uterine Sparing Technologies) Study

Study Purpose and Objectives

The purpose of this study is to evaluate the economic burden, safety and outcomes of three uterine-conserving treatment alternatives for symptomatic uterine fibroids: myomectomy, uterine artery embolization (UAE) and radiofrequency volumetric fibroid ablation using the Acessa™ System. In this study, subjects who have symptomatic uterine fibroids will be randomized to one of three uterine-conserving treatments based on the local standard of care.

Study Design

This is a post-market, randomized, prospective, multi-center, longitudinal, comparative study to evaluate the costs and health outcomes of the Acessa procedure vs. the standard uterine conserving technologies (myomectomy and UAE) for the treatment of symptomatic uterine fibroids in women who desire uterine conservation.

  • Group 1 will consist of women who desire uterine preservation and who are candidates for myomectomy. Group 1 women will be randomized 1:1 to Acessa or myomectomy (laparoscopic or abdominal).
  • Group 2 will consist of women who desire uterine preservation, but who are candidates for UAE. Group 2 women will be randomized 1:1 to Acessa or uterine artery embolization (UAE).

Sites may participate in Groups 1 and/or Group 2, depending on the availability of uterine conserving technologies and the local standard care pathway.

All eligible study subjects who are randomized to treatment will be expected to continue participation in the study for up to 60 months following treatment. Subject participation will include evaluations pre-procedure (baseline), immediate post-procedure and office or phone follow-up visits at 1 week and 4-8 weeks post-treatment. Telephone follow-up will occur at 24 to 72 hours post-treatment. Questionnaires will be distributed at baseline, 3, 6, 12, 24, 36, 48, and 60 months post-procedure. Complications and reinterventions data will be collected for up to 60 months post-treatment. Cost data pertaining to the treatment of the fibroids will be collected at the following time points: hospitalization (including the surgical procedure), post-procedure recovery, and post discharge up to 60 months.

Inclusion Criteria

Women who:

  • Are ≥ 18 years old and menstruating
  • Have symptomatic uterine fibroids
  • Have a uterine size ≤16 gestational weeks as determined by pelvic exam
  • Have all fibroids that are less than 10 cm in any diameter
  • Desire uterine conservation
  • Have had a normal Pap smear within the past 36 months defined as “no untreated cervical malignancy or dysplasia”
  • Are willing and able to comply with all study tests, procedures and assessment tools
  • Are capable of providing informed consent

Exclusion Criteria

Women who:

  • 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)
  • Are pregnant or lactating
  • Have taken any depot 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 10 days prior to treatment
  • Have chronic pelvic pain known to not be 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
  • Should not participate in the study in the medical opinion of the investigator
  • Are not willing to be randomized to treatment

If you are interested in learning more about this study, please refer to the clinicaltrials.gov website: http://www.clinicaltrials.gov/ct2/show/NCT02163525?term=Halt+medical&rank=5 (USA) or http://www.clinicaltrials.gov/ct2/show/NCT01563783?term+TRUST&rank=3 (Canada)

ClinicalTrials.gov Identifiers:
NCT02163525 and NCT01563783

LI-00-0211-D

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

Study Purpose and Objectives

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 Acessa System. Laparoscopic ultrasound (LUS) is a standard step prior to the Acessa procedure but has not been a standard step prior to LM. Incorporating LUS 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.

The primary objective of this study is to compare the mean time to discharge from the hospital following laparoscopic treatment of fibroids by either myomectomy or by Acessa. Secondary objectives are to compare multiple safety and efficacy outcome measures, mainly complications, readmissions and reintervention rates, post-op use of pain medication, recovery rates including return to work, post-treatment changes in the severity of fibroid related symptoms including menstrual changes, post-treatment changes in health-related quality of life and general health status and overall patient satisfaction with the treatment.

Study Design

This is a post-market, randomized, prospective, single center, longitudinal, comparative study to evaluate the outcomes of GFA vs the current standard of care at a single center (laparoscopic myomectomy) for the treatment of symptomatic uterine fibroids in women who desire uterine conservation.

Fifty subjects recruited from referral centers within Germany have been treated. All subjects recruited consisted of women who desired uterine preservation and who were willing to be randomized. All study subjects will be expected to continue participation in the study for 60 months following treatment. The multiple endpoints of the clinical investigation will be assessed and reported at various intervals.

This study is currently closed to enrollment and all subjects are in follow-up.

Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Study and Registry

If you are interested in learning more about this study or the registry, please refer to fibroids.ucsf.edu or the clinicaltrials.gov website: http://www.clinicaltrials.gov/ct2/show/NCT01840124?term=acessa&rank=2 (Study) or
http://www.clinicaltrials.gov/ct2/show/NCT02100904?term=NCT02100904&rank=1 (Registry)

University of California, Davis
Davis, California, United States
Contact: Sarah Steimer sarah.stemier@ucdmc.ucdavis.edu

University of California, Irvine
Irvine, California, United States
Contact: Naghmeh S. Saberi, MD 714-456-5694
Contact: Mark Vuchinich, MD 714-456-5694

University of California, San Diego
La Jolla, California, United States
Contact: Vanessa Candare 858-657-1299

University of California, Los Angeles
Los Angeles, California, United States
Contact: Ram K.Paarvatane 310-825-5255 uclaobgynresearch@mednet.com
Contact: Nicole Pennington 310-794-9652

University of California, San Francisco
San Francisco, California, United States
Contact: Stephanie Lemp 415-297-3114 lemps@obgyn.ucsf.edu
Contact: Lisa Abinanti 415-353-9978 lisa.abinanti@ucsf.edu

You may also refer to the clinicaltrials.gov website:
ClinicalTrials.gov Identifiers: NCT01840124 and NCT02100904

LI-00-0351-A
X
- Enter Your Location -
- or -