Clinical Studies and Associated Publications

Four 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 significantly improved quality of life. The following are descriptions of the clinical trial publications to date:

International Trials of the Acessa System

Berman, et al described the three 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. Mean scores representing reduction in symptom severity, improvement in health-related quality of life, and improvement in general health state were maintained. The full article will be 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.

- Click here to read the abstract.

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

- Click here to read the full article

Chudnoff, et al, wrote “Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas,” which was published on-line by Obstetrics and Gynecology in November 2012 and in print in May 2013. This paper provides a full account of the first 12-month outcomes for the 135 women who were highly symptomatic and were treated with the Acessa System. Subjects were followed objectively for menstrual blood loss, uterine volume, and fibroid volume. 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.

- Click here to read the abstract

Brucker, et al, introduced the first randomized, prospective study of 50 patients who received laparoscopic fibroid treatment with either Acessa or myomectomy. This study was also presented at the various medical meetings and follow up of the treated subjects continues for a total of 5 years. 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. 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.

- Click here to read the open access article

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. The authors describe the pretreatment levels of menstrual bleeding (objectively measured by alkaline hematin) and the associated fibroid types, the treatment with Acessa, and the resulting menstrual bleeding outcomes at 12 months. Of those study subjects with classic intramural myomas (those not abutting the endometrium) and void of any submucous myomas, not only did they have relatively high AH values but fibroid treatment with Acessa resulted in a clinically and statistically significant reduction in menstrual blood loss.

- Click here to read the abstract.

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.” This retrospective analysis of the preoperative and operative imaging data in 135 treated women demonstrated that laparoscopic ultrasound used during the Acessa treatments was twice as effective in detecting myomas compared to transvaginal ultrasound and also superior to contrast-enhanced magnetic resonance imaging.

- Click here to read the abstract.

Galen, et al, published an article comparing the feasibility study results with the one year results from the international trial. All studies (total 206 subjects) showed a post-treatment median of 4-5 days return-to-work, significant reduction in uterine volume, and significant improvements symptoms, health, and quality of life. 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).

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 interesting case study within the article.   The full article is available in OBG Management November 2013 | Vol. 25, No. 11: 50-55.

- Click here for the online version.


 Three clinical studies have been published demonstrating the effectiveness and durability of the Acessa™ Procedure for the treatment of uterine fibroids. The results from these trials consistently show reduction in uterine size, significantly decreased symptom severity, and significantly improved quality of life for Acessa patients.

Feasibility and Confirmatory Studies

Jose Garza-Leal et al published the Acessa feasibility study (“Laparoscopic Ultrasound-Guided Radiofrequency Volumetric Thermal Ablation of Symptomatic Uterine Leiomyomas: Feasibility Study Using the Halt 2000 Ablation System”) in the May/June 2011 issue of The Journal of Minimally Invasive Gynecology. The authors demonstrated that laparoscopic ultrasound-guided volumetric thermal ablation (RFVTA) of fibroids using the Acessa System significantly reduced patient-reported fibroid symptoms and improved patient quality of life.

- Click here to read the abstract.

Robles and coauthors wrote and published “Laparoscopic Radiofrequency Volumetric Thermal Ablation of Uterine Myomas With 12 Months of Follow-Up” in the International Journal of Gynecology and Obstetrics. Their study confirmed the results of the Garza study and concluded that RFVTA of fibroids resulted in significantly decreased symptoms and improved quality of life for the patients who underwent treatment. This 2012 paper is available online and in print through the journal.

- Click here to read the absract.

Ongoing International Trial of the Acessa System

Chudnoff et al wrote “Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas,” which was published on-line by Obstetrics and Gynecology in November 2012 and in print in May 2013. This paper provides a full account of the first 12-month outcomes for the 135 women who were highly symptomatic and were treated with the Acessa System. Subjects were followed objectively for menstrual blood loss, uterine volume, and fibroid volume. 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.

- Click here to read abstract.

Guido et al followed Chudnoff’s paper with a discussion of the long-term outcomes of the 124 women who were followed to two years in the same clinical trial: “Radiofrequency Volumetric Thermal Ablation of Symptomatic Fibroids: Two Years’ Outcome from the Halt Trial. 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.

Read the full article: http://www.hqlo.com/content/pdf/1477-7525-11-139

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. The authors describe the pretreatment levels of menstrual bleeding (objectively measured by alkaline hematin) and the associated fibroid types, the treatment with Acessa, and the resulting menstrual bleeding outcomes at 12 months. Of those study subjects with classic intramural myomas (those not abutting the endometrium) and void of any submucous myomas, not only did they have relatively high AH values but fibroid treatment with Acessa resulted in a clinically and statistically significant reduction in menstrual blood loss.

- Click here to read the abstract.

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.” This retrospective analysis of the preoperative and operative imaging data in 135 treated women demonstrated that laparoscopic ultrasound used during the Acessa treatments was twice as effective in detecting myomas compared to transvaginal ultrasound and also superior to contrast-enhanced magnetic resonance imaging.

- Click here to read the abstract.

 

 

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