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The ADVANCED WOMENS HEALTH INSTITUTE has been selected to participate in an FDA supervised study of a novel device for the minimally invasive treatment of fibroid tumors. The following letter is or has been sent to various OB/GYN and Family Practice doctors.

Dear Colleague,

 

We are excited about being invited to participate in an FDA supervised study entitled:

 Evaluation of the Gynesonics System for Transcervical Treatment of

Symptomatic Uterine Fibroids with Radiofrequency Ablation under Integrated Intrauterine Sonography Guidance

Sonography Guided Transcervical Ablation of Uterine Fibroids

 (SONATA)

 Protocol No: CL 04502

 Women aged 25-50 with heavy menstrual bleeding due to fibroids and have no desire for future fertility may qualify. Your patient will be cared for, per protocol, at no cost to her. There is a stipend for patient participation to cover time and travel.

 SONATA has already shown to be safe and effective in the pivotal European study. In general, a woman can have SONATA on a Friday and return to work on Monday. Over the next 3-6 months she should see a significant reduction in her fibroid related problems.

 To know more about the SONATA study and VizAblate technology go to www.Gynesonics.com. In short, your patient has an in office IV sedation case. A needle is guided with ultrasound into her fibroid. RFA(radio frequency ablation) is then performed. Post SONATA pain is usually minimal.

 All your fibroid patient needs to do is call our office 303-321-2255, indicate they are interested in the SONATA study and ask for Donnis or Lenzy. Our study coordinators will ask them a few questions to see if they qualify. We will keep you advised about your patient’s care.

Sincerely,

Michael L. Moore, MD

Oralee Ekberg DO