Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies
Currently there are no optimal methods for treating symptomatic uterine fibroids. Existing
therapeutic options are conservative (medications), invasive (e.g., hysterectomy, surgical
myomectomy), or minimally invasive (uterine artery embolization, or myolysis).
Fibroid ablation using cryogenic energy, known as Cryoablation, offers a potential
alternative method of fibroid treatment. Cryotherapy is a well-established technique for the
treatment of various benign and malignant conditions. Cryoablation has been described for
the treatment of prostate cancer, renal cell carcinoma, liver tumors and benign and
malignant breast tumors.
Galil Medical's proposed feasibility study is looking to examine the technical success,
safety and feasibility of a hysteroscopic approach for the treatment of symptomatic
fibroids. This technique involves the insertion and placement of Galil Medical's 17-gauge
cryoablation needle(s)guided by a hysteroscopic device. Ultrasound provides real-time
monitoring of the needle insertion, placement and iceball propagation during the
This treatment offers the patient to preserve her uterus by a minimally invasive procedure.
The type of the fibroids intended for treatment (Type II submucous myomas)are often very
difficult to completely and safely remove hysteroscopically and are often treated through an
open or laparoscopic procedure. A hysteroscopic procedure does not involve intraperitoneal
intervention and is therefore expected to be associated with less intra-operative and
The recovery from hysteroscopic cryoablation is expected to be fast with only minimal self
resolving discomfort. The patient should be able to return to her normal activity within
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Adverse Events
Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)
up to 4 weeks post procedure.
Andreas L Thurkow
St.Lucas Andreas Ziekenhuis
Netherlands: Medical Ethics Review Committee (METC)
UFHYS_WH_ 121207 VER 0.1