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Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galil Medical
ClinicalTrials.gov Identifier:
NCT00731341
First received: August 7, 2008
Last updated: October 25, 2011
Last verified: October 2011
  Purpose

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 Intervention
Uterine Fibroids
Leiomyoma
Menorrhagia
Procedure: Cryoablation for the treatment of uterine fibroids

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Galil Medical:

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


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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

  • Time (in Days) to Return to Normal Activity [ Time Frame: 4 weeks post procedure ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Discharged on Day of Cryoablation Procedure. [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
    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.

  • Evaluation of Length of an Average Cryoablation Procedure [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
    Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids

  • Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
    Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).


Enrollment: 3
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731341

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

No publications provided

Responsible Party: Galil Medical
ClinicalTrials.gov Identifier: NCT00731341     History of Changes
Other Study ID Numbers: UFHYS_WH_ 121207 VER 0.1
Study First Received: August 7, 2008
Results First Received: August 12, 2010
Last Updated: October 25, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on November 20, 2014