cryoablation myoma freezing
Conditions
Interventions
Hysteroscopic cryomyolysis under visual ultrasound guidance
Sponsors
Galil Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AE) up to 4 weeks post procedure. 2) Technical success and procedure feasibility will be assessed by: o Identification of fibroid under ultrasound o Visibility of needles under ULS o Insertion of needles to the fibroid and positioning of the needle in the fibroid o Visibility of the fibroid and needle by the hysterospcope optics o Visibility of ice ball propagation and fibroid optimal coverage o Type of fibroid and location and impact on success rate | — |
Secondary
| Measure | Time frame |
|---|---|
| o Hysteroscopic cryomyolysis related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) completed by the patient prior to discharge from hospital. o Time (in days) to return to normal activity (reported by the patient at 4 weeks follow-up visit and recorded in the CRF). o Average duration of post operative hospital stay. o Evaluation of length of an average procedure. o Physician's satisfaction from the ease and convenience of the hysteroscopic cryoablation procedure will be documented in a satisfaction questionnaire. | — |
Countries
Netherlands
Outcome results
None listed