Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

Study Overview
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Brief Summary
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The purpose of the current study is to evaluate the technical success, safety and procedure feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women who do not desire further pregnancies using Galil Medical's 17-gauge 400mm Argon-based cryoablation needles

Detailed Description
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Currently there are no optimal methods for treating symptomatic uterine fibroids. Existing therapeutic options are conservative (medications), invasive (e.g., hysterectomy, surgical myomectomy), or minimally invasive (uterine artery embolization, or myolysis). Fibroid ablation using cryogenic energy, known as Cryoablation, offers a potential alternative method of fibroid treatment. Cryotherapy is a well-established technique for the treatment of various benign and malignant conditions. Cryoablation has been described for the treatment of prostate cancer, renal cell carcinoma, liver tumors and benign and malignant breast tumors. Galil Medical's proposed feasibility study is looking to examine the technical success, safety and feasibility of a hysteroscopic approach for the treatment of symptomatic fibroids. This technique involves the insertion and placement of Galil Medical's 17-gauge cryoablation needle(s)guided by a hysteroscopic device. Ultrasound provides real-time monitoring of the needle insertion, placement and iceball propagation during the cryoablation procedure. This treatment offers the patient to preserve her uterus by a minimally invasive procedure. The type of the fibroids intended for treatment (Type II submucous myomas)are often very difficult to completely and safely remove hysteroscopically and are often treated through an open or laparoscopic procedure. A hysteroscopic procedure does not involve intraperitoneal intervention and is therefore expected to be associated with less intra-operative and post-operative complications. The recovery from hysteroscopic cryoablation is expected to be fast with only minimal self resolving discomfort. The patient should be able to return to her normal activity within 24-48 hours.

Official Title
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Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies

Conditions
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Uterine Fibroids, Leiomyoma, Menorrhagia

Intervention / Treatment
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* Procedure: Cryoablation for the treatment of uterine fibroids


Participation Criteria
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Eligibility Criteria
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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 Fibroids type, size, location and number 1 submucosal fibroid Type I and Type II fibroids 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 Fibroids Size > 4cm 2 or more submucosal fibroids Fibroid distance from the serosa is less than 1 cm

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hysteroscopic cryoablation<br>Women undergoing hysteroscopic ultrasound guided cryoablation for the treatment of uterine fibroids. | Procedure: Cryoablation for the treatment of uterine fibroids<br>* Needle will be inserted into the fibroid via the cervix through a hysteroscope channel. Gas is circulated through the sealed needle to form an iceball at the tip. After insertion, the needle will be cooled to a temperature of below -100°C to freeze the tissue of the fibroid.<br>* Other names: 17-gauge IceBulb™ needle Lot G3021;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs) | up to 4 weeks post procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient | Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) from a scale of 1 (no pain) to 10 (very severe pain) completed by the patient | Prior to hospital discharge (less than 24 hours post-procedure) | 
| Time (in Days) to Return to Normal Activity | The number of days needed to return to normal activity was assessed by the participant and reported to the investigator. The response was documented at follow-up. | 4 weeks post procedure | 
| Number of Participants Discharged on Day of Cryoablation Procedure. | Per the protocol, this outcome intended to report the average duration of post operative hospital stay. However, this measurement was made very generally and was not collected in number of hours, only the dates were collected. The only actual data that can be stated is that all subjects were discharged from the hospital on the same day as the procedure. In order to report the average length of hospital stay, the wording on the outcome measure title has been changed. | Post procedure | 
| Evaluation of Length of an Average Cryoablation Procedure | Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids | Post procedure | 
| Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure | Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied). | Post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine fibroids, Leiomyoma, Menorrhagia, Hysteroscopic cryoablation, Minimally invasive