NCT00731341

Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Female
• Age: 30 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Uterine Fibroids
• Leiomyoma
• Menorrhagia

Interventions

Type	Name	Description
PROCEDURE	Cryoablation for the treatment of uterine fibroids	Needle will be inserted into the fibroid via the cervix through a hysteroscope channel. Gas is circulated through the sealed needle to form an iceball at the tip. After insertion, the needle will be cooled to a temperature of below -100°C to freeze the tissue of the fibroid.

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-08-11
• Last updated: 2021-07-19
• Results posted: 2011-07-01

Locations

1 site across 1 country: Netherlands