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Cryoablation of Symptomatic Uterine Fibroids Using the IceSense3™ System in a Percutaneous Laparoscopic-assisted Approach

30 Years
50 Years
Not Enrolling
Symptomatic Uterine Fibroids

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Trial Information

Cryoablation of Symptomatic Uterine Fibroids Using the IceSense3™ System in a Percutaneous Laparoscopic-assisted Approach

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

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

14. Patient has any contraindication for laparoscopic surgery

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement in patient's fibroid-related quality of life

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Moty Pansky, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assaf Harofe Hospital, Israel


Israel: Ethics Commission

Study ID:




Start Date:

December 2012

Completion Date:

Related Keywords:

  • Symptomatic Uterine Fibroids
  • cryoablation
  • uterine fibroid
  • uterine myoma
  • who completed her family planning
  • but wishes to preserve her uterus
  • Leiomyoma
  • Myofibroma