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The SONATA Study: Sonography-Guided Transcervical Ablation of Uterine Fibroids
Abstracts / Journal of Minimally Invasive Gynecology 22 (2015) S1–S253 Measurements and Main Results: We found a significant decrease in the percent of cases performed through an open approach over the course of the study, with a concurrent significant increase in the percent of robotic procedures. There was also a decrease in the number of cases performed vaginally over this period, but this was only observed at the community hospital site.
Conclusion: At our larger, teaching hospital, the implementation of a comprehensive robotic training program was associated with a significant decrease in procedures performed through an open approach with a concurrent proportionate increase in laparoscopic ( and specifically robotic) procedures. This was not associated with a decline in vaginal hysterectomies. At our smaller, community hospital, more dramatic increases were observed with respect to the percent of hysterectomies performed robotically; however, a decline in the percent of cases performed vaginally was also observed.
102
Open Communications 6 - New Instruments (2:15 PM - 3:15 PM)
The SONATA Study: Sonography-Guided Transcervical Ablation of Uterine Fibroids Guido R,1 Makai G,2 Roy K,3 Chudnoff S,4 Moore M,5 Berman J.6 1 Magee-Women’s Hospital, Pittsburgh, Pennsylvania; 2Christiana Care Health Services, Newark, Delaware; 3Arizona Gynecology Consultants, Phoenix, Arizona; 4Montefiore Medical Center, New York, New York; 5 Advanced Women’s Health, Denver, Colorado; 6Wayne State University, Southfield, Michigan Study Objective: To establish the safety and effectiveness of the SonataÔ System in the treatment of symptomatic uterine fibroids. Design: Prospective, longitudinal, multicenter, single-arm trial. Setting: Up to 22 clinical sites in the US and Mexico. Patients: 147 women with heavy menstrual bleeding secondary to fibroids; a minimum MP score of 150 is required for subject inclusion. A sample of 125 subjects is sufficient to detect a reduction in menstrual blood loss at 12 months with a lower confidence limit of R 45% and an assumed 60% subject success rate. Intervention: Transcervical, intrauterine ultrasound-guided radiofrequency ablation performed on up to 6 fibroids per subject ranging from 1-5 cm in diameter as determined by transvaginal sonography. Anesthesia is at the discretion of each investigator and choices include conscious sedation, regional anesthesia and general anesthesia. Measurements and Main Results: The study is in progress and the current status of the study will be presented. The co-primary endpoints, both reached at 12 months, are menstrual blood loss reduction and absence of surgical reintervention. Additional assessments include the UFS-QOL, EQ-5D and Overall Treatment Effect questionnaires, as well as patient satisfaction, safety and reduction in perfused and total fibroid volume. Conclusion: The SONATA Study is an ongoing clinical trial in the US and Mexico to confirm safety and efficacy of a new transcervical device to ablate uterine fibroids with radiofrequency energy under built-in intrauterine sonography guidance.
S41
103 Early Clinical Response to Intrauterine Ultrasound-Guided Transcervical Radiofrequency Ablation Br€olmann H,1 Bongers M,2 Gupta J,3 Garza-Leal JG,4 Quartero R,5 Veersema S,6 Toub DB.7 1Vrije Universiteit Medisch Centrum, Amsterdam, Netherlands; 2Maxima Medisch Centrum, Veldhoven, Netherlands; 3 Birmingham Women’s Hospital, Birmingham, United Kingdom; 4Hospital Universitario ‘‘Dr. Jose Eleuterio Gonzalez’’ de Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon, Mexico; 5Medisch Spectrum Twente, Enschede, Netherlands; 6St. Antonius Ziekenhuis, Nieuwegein, Netherlands; 7Gynesonics, Redwood City, California Study Objective: To report early clinical responses to transcervical radiofrequency ablation of uterine fibroids. Design: Prospective, longitudinal, multicenter, single-arm trial. Setting: Academic and community hospitals in the United Kingdom, The Netherlands and Mexico. Patients: 50 women with heavy menstrual bleeding secondary to fibroids. A sample of 40 subjects was sufficient to detect a difference of 22% in the probability of success with a power of 82% using a one-group chi-square test with a 0.05 two-sided significance level. Intervention: Radiofrequency ablation guided by built-in intrauterine sonography (the SonataÔ System). Measurements and Main Results: Fibroid symptoms were captured using the Menstrual Pictogram (MP) and the UFS-QOL Symptom Severity Score (SSS) and Health-Related Quality of Life (HRQOL) subscales. At three months, the MP (n = 49) and SSS (n = 50) scores were reduced on average by 45.2% 57.9% and 46.7% 32.8%, respectively. The HRQOL (n = 48) subscale improved by 342% 854%. At three months, 77.5% of patients experienced a clinically significant reduction (R 22%) in menstrual bleeding, with 57.1% of patients realizing a reduction above 50%. Conclusion: Transcervical radiofrequency ablation with the Sonata System produced clinical benefits, including reduction in menstrual bleeding, within three months in the majority of patients. 104 Face- and Content Validity of a New Portable Tablet Box Trainer for Training Laparoscopic Skills at Home Aa JVD,1 Schraffordt Koops S,2 Santbrink EV,3 Schreuder H.1 1 Obstetrics & Gynecology, University Medical Center Utrecht, Utrecht, Netherlands; 2Obstetrics & Gynecology, Meander Medical Center, Amersfoort, Utrecht, Netherlands; 3Reproductive Medicine, Reinier de Graaf Hospital, Voorburg, Zuid Holland, Netherlands Study Objective: The aim of this study was to establish face- and content validity for a new portable box trainer and to see if residents would be interested to use this for training at home. Design: Prospective study. Setting: National laparoscopy courses. Assessment for home training of the simulator Opinion The simulator is easy to use The simulator is valuable for residents to train at home The simulator should be introduced in the residency curriculum The simulator should be provided by the hospital If I had this simulator I would use it for practice at home
Median (range) 5 (4-5) 4.5 (4-5) 4 (3-5) 5 (3-5) 5 (2-5)
5-point Likert scale: 1=strongly unappreciated; 2=unappreciated; 3= undecided; 4=appreciated; 5=strongly appreciated.
Conclusion: At our larger, teaching hospital, the implementation of a comprehensive robotic training program was associated with a significant decrease in procedures performed through an open approach with a concurrent proportionate increase in laparoscopic ( and specifically robotic) procedures. This was not associated with a decline in vaginal hysterectomies. At our smaller, community hospital, more dramatic increases were observed with respect to the percent of hysterectomies performed robotically; however, a decline in the percent of cases performed vaginally was also observed.
102
Open Communications 6 - New Instruments (2:15 PM - 3:15 PM)
The SONATA Study: Sonography-Guided Transcervical Ablation of Uterine Fibroids Guido R,1 Makai G,2 Roy K,3 Chudnoff S,4 Moore M,5 Berman J.6 1 Magee-Women’s Hospital, Pittsburgh, Pennsylvania; 2Christiana Care Health Services, Newark, Delaware; 3Arizona Gynecology Consultants, Phoenix, Arizona; 4Montefiore Medical Center, New York, New York; 5 Advanced Women’s Health, Denver, Colorado; 6Wayne State University, Southfield, Michigan Study Objective: To establish the safety and effectiveness of the SonataÔ System in the treatment of symptomatic uterine fibroids. Design: Prospective, longitudinal, multicenter, single-arm trial. Setting: Up to 22 clinical sites in the US and Mexico. Patients: 147 women with heavy menstrual bleeding secondary to fibroids; a minimum MP score of 150 is required for subject inclusion. A sample of 125 subjects is sufficient to detect a reduction in menstrual blood loss at 12 months with a lower confidence limit of R 45% and an assumed 60% subject success rate. Intervention: Transcervical, intrauterine ultrasound-guided radiofrequency ablation performed on up to 6 fibroids per subject ranging from 1-5 cm in diameter as determined by transvaginal sonography. Anesthesia is at the discretion of each investigator and choices include conscious sedation, regional anesthesia and general anesthesia. Measurements and Main Results: The study is in progress and the current status of the study will be presented. The co-primary endpoints, both reached at 12 months, are menstrual blood loss reduction and absence of surgical reintervention. Additional assessments include the UFS-QOL, EQ-5D and Overall Treatment Effect questionnaires, as well as patient satisfaction, safety and reduction in perfused and total fibroid volume. Conclusion: The SONATA Study is an ongoing clinical trial in the US and Mexico to confirm safety and efficacy of a new transcervical device to ablate uterine fibroids with radiofrequency energy under built-in intrauterine sonography guidance.
S41
103 Early Clinical Response to Intrauterine Ultrasound-Guided Transcervical Radiofrequency Ablation Br€olmann H,1 Bongers M,2 Gupta J,3 Garza-Leal JG,4 Quartero R,5 Veersema S,6 Toub DB.7 1Vrije Universiteit Medisch Centrum, Amsterdam, Netherlands; 2Maxima Medisch Centrum, Veldhoven, Netherlands; 3 Birmingham Women’s Hospital, Birmingham, United Kingdom; 4Hospital Universitario ‘‘Dr. Jose Eleuterio Gonzalez’’ de Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon, Mexico; 5Medisch Spectrum Twente, Enschede, Netherlands; 6St. Antonius Ziekenhuis, Nieuwegein, Netherlands; 7Gynesonics, Redwood City, California Study Objective: To report early clinical responses to transcervical radiofrequency ablation of uterine fibroids. Design: Prospective, longitudinal, multicenter, single-arm trial. Setting: Academic and community hospitals in the United Kingdom, The Netherlands and Mexico. Patients: 50 women with heavy menstrual bleeding secondary to fibroids. A sample of 40 subjects was sufficient to detect a difference of 22% in the probability of success with a power of 82% using a one-group chi-square test with a 0.05 two-sided significance level. Intervention: Radiofrequency ablation guided by built-in intrauterine sonography (the SonataÔ System). Measurements and Main Results: Fibroid symptoms were captured using the Menstrual Pictogram (MP) and the UFS-QOL Symptom Severity Score (SSS) and Health-Related Quality of Life (HRQOL) subscales. At three months, the MP (n = 49) and SSS (n = 50) scores were reduced on average by 45.2% 57.9% and 46.7% 32.8%, respectively. The HRQOL (n = 48) subscale improved by 342% 854%. At three months, 77.5% of patients experienced a clinically significant reduction (R 22%) in menstrual bleeding, with 57.1% of patients realizing a reduction above 50%. Conclusion: Transcervical radiofrequency ablation with the Sonata System produced clinical benefits, including reduction in menstrual bleeding, within three months in the majority of patients. 104 Face- and Content Validity of a New Portable Tablet Box Trainer for Training Laparoscopic Skills at Home Aa JVD,1 Schraffordt Koops S,2 Santbrink EV,3 Schreuder H.1 1 Obstetrics & Gynecology, University Medical Center Utrecht, Utrecht, Netherlands; 2Obstetrics & Gynecology, Meander Medical Center, Amersfoort, Utrecht, Netherlands; 3Reproductive Medicine, Reinier de Graaf Hospital, Voorburg, Zuid Holland, Netherlands Study Objective: The aim of this study was to establish face- and content validity for a new portable box trainer and to see if residents would be interested to use this for training at home. Design: Prospective study. Setting: National laparoscopy courses. Assessment for home training of the simulator Opinion The simulator is easy to use The simulator is valuable for residents to train at home The simulator should be introduced in the residency curriculum The simulator should be provided by the hospital If I had this simulator I would use it for practice at home
Median (range) 5 (4-5) 4.5 (4-5) 4 (3-5) 5 (3-5) 5 (2-5)
5-point Likert scale: 1=strongly unappreciated; 2=unappreciated; 3= undecided; 4=appreciated; 5=strongly appreciated.