Laparoscopic Cryoablation of Uterine Fibroids

NCT ID: NCT01735812

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Symptomatic Uterine Fibroids

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

symptomatic UF

Group Type: EXPERIMENTAL

IceSense3 system

Intervention Type: DEVICE

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

Interventions

IceSense3 system

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IceCure Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moty Pansky, Prof.

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofe Hospital, Israel

Locations

Assaf Harofe

Zrifin, , Israel

Countries

Israel

Other Identifiers

ICUFL-01

Identifier Type: -

Identifier Source: org_study_id