CompletedNot Applicable

Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

Netherlands3 participantsStarted 2008-07

Plain-language 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

Who can participate

Age range

30 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Adverse Events

Timeframe: up to 4 weeks post procedure.

Trial details

NCT IDNCT00731341

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-02

Results submitted2010-08-12

View on ClinicalTrials.gov More Uterine Fibroids trials