Clinical trial NCT00731341: Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata
Official title: Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Leiomyoma
Menorrhagia
Keywords: Uterine fibroids
Leiomyoma
Menorrhagia
Hysteroscopic cryoablation
Minimally invasive
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 3
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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
* 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

Primary outcomes:
measure: Number of Adverse Events
timeFrame: up to 4 weeks post procedure.
Secondary outcomes:
measure: Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient
timeFrame: Prior to hospital discharge (less than 24 hours post-procedure)
measure: Time (in Days) to Return to Normal Activity
timeFrame: 4 weeks post procedure
measure: Number of Participants Discharged on Day of Cryoablation Procedure.
timeFrame: Post procedure
measure: Evaluation of Length of an Average Cryoablation Procedure
timeFrame: Post procedure
measure: Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure
timeFrame: Post procedure
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: St.Lucas Andreas Ziekenhuis
Study officials:
affiliation: St.Lucas Andreas Ziekenhuis
name: Andreas L Thurkow
role: PRINCIPAL_INVESTIGATOR
References: