UFREEZE-01: Laparoscopic Cryoablation of Uterine Fibroids

Sponsor
IceCure Medical Ltd. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01735812
Collaborator
(none)
0
1
1
36
0

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: IceSense3 system
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cryoablation of Symptomatic Uterine Fibroids Using the IceSense3™ System in a Percutaneous Laparoscopic-assisted Approach
Actual Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: symptomatic UF

Device: IceSense3 system
The IceSense3™ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications.

Outcome Measures

Primary Outcome Measures

  1. Improvement in patient's fibroid-related quality of life [12 months]

    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.

  2. Incidence, subsequent interventions and procedure-related adverse events [12 months]

    To evaluate procedural safety by monitoring incidence, subsequent interventions and procedure-related adverse events within 12 months of treatment

Secondary Outcome Measures

  1. Reduction in fibroid volume [12 months]

    Reduction in fibroid volume as measured by US/MRI imaging at 6 and 12 months follow-up post treatment comparing to baseline.

  2. Improvement in menstrual bleeding [12 months]

    Improvement in menstrual bleeding compared to baseline as measured in chemical analysis (Alkaline haematin technique) at 6 and 12 months post treatment.

  3. Improvement in patient's fibroid-related quality of life [6 months]

    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

  1. Patient's and physician's overall treatment evaluation [12 months]

    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.

  2. Patient blood loss [12 months]

    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.

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Assaf Harofe Zrifin Israel 70300

Sponsors and Collaborators

  • IceCure Medical Ltd.

Investigators

  • Principal Investigator: Moty Pansky, Prof., Assaf Harofe Hospital, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IceCure Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01735812
Other Study ID Numbers:
  • ICUFL-01
First Posted:
Nov 28, 2012
Last Update Posted:
Jun 13, 2022
Last Verified:
Nov 1, 2012

Study Results

No Results Posted as of Jun 13, 2022