NCT01735812

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 13, 2022

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

November 26, 2012

Last Update Submit

June 9, 2022

Conditions

Symptomatic Uterine Fibroids

Keywords

cryoablationuterine fibroiduterine myomawho completed her family planningbut wishes to preserve her uterus

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Reduction in fibroid volume

    12 months

  • Improvement in menstrual bleeding

    12 months

  • Improvement in patient's fibroid-related quality of life

    6 months

Other Outcomes (2)

  • Patient's and physician's overall treatment evaluation

    12 months

  • Patient blood loss

    12 months

Study Arms (1)

symptomatic UF

EXPERIMENTAL
Device: IceSense3 system

Interventions

IceSense3 systemDEVICE

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

symptomatic UF

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pre-menopausal woman between the ages of 30 and 50 (inclusive)
  • Patient had completed her family planning and does not desire future childbearing.
  • Patient is suffering from menorrhagia as a result of symptomatic uterine fibroids.
  • Patient's uterus size is smaller than 18 gestational weeks.
  • Patient wishes to preserve her uterus and avoid hysterectomy.
  • Patient has 1-3 treatable uterine fibroids in size of up to 10cm measured by US/MRI.
  • Overall treated fibroid volume is ≤ 3,138cm3 (width x length x height x 0.523)
  • Patient has clinical menorrhagia as indicated by menstrual blood loss of ≥160 ml during one baseline cycle prior to treatment.
  • Patient is able to visit the clinic as needed during the 1 year follow-up period following the treatment.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofe

Zrifin, 70300, Israel

Location

MeSH Terms

Conditions

LeiomyomaMyofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective TissueConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Moty Pansky, Prof.

    Assaf Harofe Hospital, Israel

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2012

First Posted

November 28, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 13, 2022

Record last verified: 2012-11

Locations

IL(1)