Laparoscopic Cryoablation of Uterine Fibroids (UFREEZE-01)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by IceCure Medical Ltd.
Sponsor:
Information provided by (Responsible Party):
IceCure Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01735812
First received: November 26, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

The goal of this study is to evaluate the safety & efficacy of cryoablation using IceCure medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.


Condition Intervention
Symptomatic Uterine Fibroids
Device: IceSense3 system

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cryoablation of Symptomatic Uterine Fibroids Using the IceSense3™ System in a Percutaneous Laparoscopic-assisted Approach

Further study details as provided by IceCure Medical Ltd.:

Primary Outcome Measures:
  • Improvement in patient's fibroid-related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate procedural efficacy by the improvement in patient's fibroid-related quality of life as assessed in scores of symptom severity subscale questionnaire (SSS-UFS-QOL) at 12 months post-treatment comparing to baseline score.

  • Incidence, subsequent interventions and procedure-related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To evaluate procedural safety by monitoring incidence, subsequent interventions and procedure-related adverse events within 12 months of treatment


Secondary Outcome Measures:
  • Reduction in fibroid volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Reduction in fibroid volume as measured by US/MRI imaging at 6 and 12 months follow-up post treatment comparing to baseline.

  • Improvement in menstrual bleeding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Improvement in menstrual bleeding compared to baseline as measured in chemical analysis (Alkaline haematin technique) at 6 and 12 months post treatment.

  • Improvement in patient's fibroid-related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in patient's fibroid-related quality of life as assessed in scores of symptom severity subscale questionnaire (SSS-UFS-QOL) at 6 months post-treatment comparing to baseline score.


Other Outcome Measures:
  • Patient's and physician's overall treatment evaluation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient's and physician's overall treatment evaluation and satisfaction will be assessed using a self-report questionnaire at 6 and 12 months post treatment.

  • Patient blood loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient blood loss will be also evaluated by Hemoglobin (Hb) level measurements at 6 and 12 months post treatment and will be compared to baseline.


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: symptomatic UF Device: IceSense3 system
The IceSense3™ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications.

  Eligibility

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

Inclusion Criteria:

  1. Pre-menopausal woman between the ages of 30 and 50 (inclusive)
  2. Patient had completed her family planning and does not desire future childbearing.
  3. Patient is suffering from menorrhagia as a result of symptomatic uterine fibroids.
  4. Patient's uterus size is smaller than 18 gestational weeks.
  5. Patient wishes to preserve her uterus and avoid hysterectomy.
  6. Patient has 1-3 treatable uterine fibroids in size of up to 10cm measured by US/MRI.
  7. Overall treated fibroid volume is ≤ 3,138cm3 (width x length x height x 0.523)
  8. Patient has clinical menorrhagia as indicated by menstrual blood loss of ≥160 ml during one baseline cycle prior to treatment.
  9. Patient is able to visit the clinic as needed during the 1 year follow-up period following the treatment.
  10. The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.

Exclusion Criteria:

  1. Patient had not finished her family planning
  2. Patient was already treated for uterine fibroids in the past (UAE, myomectomy, HIFU,…) or undergone endometrial ablation.
  3. Patient had been treated with GnRH over the last 3 months.
  4. Patient has known symptomatic endometriosis that cannot be completely removed during laparoscopic procedure.
  5. Patient has known or suspected adenomyosis
  6. Patient had any active abdominal/pelvic inflammatory disease.
  7. Patient has known or suspected gynecologic malignancy.
  8. Patient with submucosal fibroids type "zero"
  9. Patient with undiagnosed vaginal bleeding
  10. Patient with blood clotting disorders
  11. Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
  12. Patient participating in other trials using drugs or devices.
  13. Patient is unable to commit all study requirements including follow-up visits and questionnaires.
  14. Patient has any contraindication for laparoscopic surgery
  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: NCT01735812

Contacts
Contact: Elisabeth Sadka, Mrs 972 4 623 0333 ext 223 Elisabeth@Icecure-medical.com
Contact: Tal Avziz, Mr. 972 4 623 0333 ext 127 tal@icecure-medical.com

Locations
Israel
Assaf Harofe Not yet recruiting
Zrifin, Israel, 70300
Contact: Moty Pansky, Prof.         
Principal Investigator: Moty Pansky, Prof         
Sponsors and Collaborators
IceCure Medical Ltd.
Investigators
Principal Investigator: Moty Pansky, Prof. Assaf Harofe Hospital, Israel
  More Information

No publications provided

Responsible Party: IceCure Medical Ltd.
ClinicalTrials.gov Identifier: NCT01735812     History of Changes
Other Study ID Numbers: ICUFL-01
Study First Received: November 26, 2012
Last Updated: November 27, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by IceCure Medical Ltd.:
cryoablation
uterine fibroid
uterine myoma
who completed her family planning
but wishes to preserve her uterus

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on October 01, 2014