Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00731341
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : July 1, 2011
Last Update Posted : November 2, 2011
Information provided by (Responsible Party):
Galil Medical

Brief 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

Condition or disease Intervention/treatment Phase
Uterine Fibroids Leiomyoma Menorrhagia Procedure: Cryoablation for the treatment of uterine fibroids Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies
Study Start Date : July 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: Hysteroscopic cryoablation
Women undergoing hysteroscopic ultrasound guided cryoablation for the treatment of uterine fibroids.
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.
Other Names:
  • Presice Cryoablation System
  • 17-gauge IceBulb™ needle Lot G3021

Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: up to 4 weeks post procedure. ]
    Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)

Secondary Outcome Measures :
  1. Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient [ Time Frame: Prior to hospital discharge (less than 24 hours post-procedure) ]
    Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) from a scale of 1 (no pain) to 10 (very severe pain) completed by the patient

  2. Time (in Days) to Return to Normal Activity [ Time Frame: 4 weeks post procedure ]
    The number of days needed to return to normal activity was assessed by the participant and reported to the investigator. The response was documented at follow-up.

  3. Number of Participants Discharged on Day of Cryoablation Procedure. [ Time Frame: Post procedure ]
    Per the protocol, this outcome intended to report the average duration of post operative hospital stay. However, this measurement was made very generally and was not collected in number of hours, only the dates were collected. The only actual data that can be stated is that all subjects were discharged from the hospital on the same day as the procedure. In order to report the average length of hospital stay, the wording on the outcome measure title has been changed.

  4. Evaluation of Length of an Average Cryoablation Procedure [ Time Frame: Post procedure ]
    Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids

  5. Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure [ Time Frame: Post procedure ]
    Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00731341

St.Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Sponsors and Collaborators
Galil Medical
Principal Investigator: Andreas L Thurkow St.Lucas Andreas Ziekenhuis

Responsible Party: Galil Medical Identifier: NCT00731341     History of Changes
Other Study ID Numbers: UFHYS_WH_ 121207 VER 0.1
First Posted: August 11, 2008    Key Record Dates
Results First Posted: July 1, 2011
Last Update Posted: November 2, 2011
Last Verified: October 2011

Keywords provided by Galil Medical:
Uterine fibroids
Hysteroscopic cryoablation
Minimally invasive

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes