Know Cancer

forgot password

Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies

30 Years
50 Years
Not Enrolling
Uterine Fibroids, Leiomyoma, Menorrhagia

Thank you

Trial Information

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
cryoablation procedure.

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
post-operative complications.

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
24-48 hours.

Inclusion Criteria:

- Primary complaint is excessive bleeding

- Subject is able to understand and give informed consent for participation in the

- Pre-menopausal woman between the ages of 30 and 50 (inclusive)

- Has completed childbearing and not contemplating future fertility

- Has symptomatic uterine fibroids

- Fibroids type, size, location and number

- 1 submucosal fibroid

- Type I and Type II fibroids

- 2 to 4cm

- Using contraception to prevent pregnancy

Exclusion Criteria:

- Any evidence of known or suspected infection or pre-malignancy/malignancy

- Desire for future child bearing

- Fibroids

- Size > 4cm

- 2 or more submucosal fibroids

- Fibroid distance from the serosa is less than 1 cm

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events

Outcome Description:

Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)

Outcome Time Frame:

up to 4 weeks post procedure.

Safety Issue:


Principal Investigator

Andreas L Thurkow

Investigator Role:

Principal Investigator

Investigator Affiliation:

St.Lucas Andreas Ziekenhuis


Netherlands: Medical Ethics Review Committee (METC)

Study ID:

UFHYS_WH_ 121207 VER 0.1



Start Date:

July 2008

Completion Date:

February 2009

Related Keywords:

  • Uterine Fibroids
  • Leiomyoma
  • Menorrhagia
  • Uterine fibroids
  • Leiomyoma
  • Menorrhagia
  • Hysteroscopic cryoablation
  • Minimally invasive
  • Leiomyoma
  • Myofibroma
  • Menorrhagia