Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

Boston Scientific

Status

Completed

Conditions

Uterine Fibroids

Leiomyoma

Menorrhagia

Treatments

Procedure: Cryoablation for the treatment of uterine fibroids

Study type

Interventional

Funder types

Industry

Identifiers

NCT00731341

UFHYS_WH_ 121207 VER 0.1

Details and patient eligibility

About

The purpose of the current study is to evaluate the technical success, safety and procedure feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women who do not desire further pregnancies using Galil Medical's 17-gauge 400mm Argon-based cryoablation needles

Full description

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.

Enrollment

3 patients

Sex

Female

Ages

30 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Primary complaint is excessive bleeding
Subject is able to understand and give informed consent for participation in the study
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