Status:
COMPLETED
Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Uterine Fibroids
Leiomyoma
Eligibility:
FEMALE
30-50 years
Phase:
NA
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 desi...
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 mi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00731341
Start Date
July 1 2008
End Date
February 1 2009
Last Update
July 19 2021
Active Locations (1)
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1
St.Lucas Andreas Ziekenhuis
Amsterdam, Netherlands