Laparoscopic Cryoablation of Uterine Fibroids

Symptomatic Uterine Fibroids Clinical Trial

— UFREEZE-01  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01735812
• Other study ID #: ICUFL-01
• Status: Withdrawn
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2012
• Source: IceCure Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Symptomatic Uterine Fibroids

Intervention

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

Locations

Country	Name	City	State
Israel	Assaf Harofe	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
IceCure Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient's and physician's overall treatment evaluation	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.	12 months
Other	Patient blood loss	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.	12 months
Primary	Improvement in patient's fibroid-related quality of life	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.	12 months
Primary	Incidence, subsequent interventions and procedure-related adverse events	To evaluate procedural safety by monitoring incidence, subsequent interventions and procedure-related adverse events within 12 months of treatment	12 months
Secondary	Reduction in fibroid volume	Reduction in fibroid volume as measured by US/MRI imaging at 6 and 12 months follow-up post treatment comparing to baseline.	12 months
Secondary	Improvement in menstrual bleeding	Improvement in menstrual bleeding compared to baseline as measured in chemical analysis (Alkaline haematin technique) at 6 and 12 months post treatment.	12 months
Secondary	Improvement in patient's fibroid-related quality of life	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.	6 months