N/A N=3 Treatment

Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

Uterine Fibroids · Leiomyoma · Menorrhagia

Bottom Line

View on ClinicalTrials.gov: NCT00731341 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2011

Primary outcome: Primary: Number of Adverse Events — 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cryoablation for the treatment of uterine fibroids (Procedure)
Age: Adult · 30+ yrs
Sex: Female
Sponsor: Boston Scientific Corporation
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Adverse Events	1	—
SECONDARY Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient	1.86	—
SECONDARY Time (in Days) to Return to Normal Activity	6	—
SECONDARY Number of Participants Discharged on Day of Cryoablation Procedure.	3	—
SECONDARY Evaluation of Length of an Average Cryoablation Procedure	65.3	—
SECONDARY Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure	4.3	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00731341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.