HYSTEROSCOPIC CRYOMYOLYSIS FOR THE TREATMENT OF SUBMUCOSAL LEIOMYOMATA

Completed

Conditions: cryoablation
myoma freezing
10038595
10029903

Registration Number: NL-OMON31767

Lead Sponsor: Galil Medical

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

* Primary complaint is excessive bleeding
* Subject is able to understand and give informed consent for participation in the study
* Pre-menopausal woman between the ages of 30 and 50 (inclusive)
* Has completed childbearing and not contemplating future fertility
* Has symptomatic uterine fibroids
o Symptomatic subjects defined as
* Abnormal uterine bleeding
* Either menorrhagia or metrorrhagia, or menometrorrhagia (with no infectious or pre-malignant/malignant cause of bleeding)
* Socially disruptive bleeding
* Bleeding defined as bothersome to the patient that interferes with daily activities
* Fibroids type, size, location and number
o 1 submucosal fibroid
o Type I and Type II fibroids
o 2 to 4cm
* Using contraception to prevent pregnancy

Exclusion Criteria

* Any evidence of known or suspected infection or pre-malignancy/malignancy
* Desire for future child bearing
* Use of GnRH analogues within 3 months prior to cryotherapy treatment
* Fibroids
o Size > 4 cm
o 2 or more submucosal fibroids
o Fibroid distance from serosa is less than 1 cm

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Safety of the procedure will be assessed by incidence and severity of intra<br /><br>and post procedure related adverse events (AE) up to 4 weeks post procedure.<br /><br>2) Technical success and procedure feasibility will be assessed by:<br /><br><br /><br>o Identification of fibroid under ultrasound<br /><br>o Visibility of needles under ULS<br /><br>o Insertion of needles to the fibroid and positioning of the needle in the<br /><br>fibroid<br /><br>o Visibility of the fibroid and needle by the hysterospcope optics<br /><br>o Visibility of ice ball propagation and fibroid optimal coverage<br /><br>o Type of fibroid and location and impact on success rate</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>o Hysteroscopic cryomyolysis related pain will be measured by self reported<br /><br>pain severity Visual Analogue Scale (VAS) completed by the patient prior to<br /><br>discharge from hospital.<br /><br><br /><br>o Time (in days) to return to normal activity (reported by the patient at 4<br /><br>weeks follow-up visit and recorded in the CRF).<br /><br><br /><br>o Average duration of post operative hospital stay.<br /><br><br /><br>o Evaluation of length of an average procedure.<br /><br><br /><br>o Physician's satisfaction from the ease and convenience of the hysteroscopic<br /><br>cryoablation procedure will be documented in a satisfaction questionnaire.</p><br>