A Study to Collect Worldwide Pregnancy Data Following ExAblate Treatment of Symptomatic Uterine Fibroids
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-003910
Sponsor Protocol Number: UF36-A
About this study
This study is being done to support a device labeling change that will allow women who have uterine fibroids and still wish to become pregnant greater access to the ExAblate treatment. In order for the Sponsor to receive permission to change the labeling, data regarding known pregnancies and their outcome are being gathered to show the known safety hazards to women who might wish to get pregnant after an ExAblate treatment
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Eligibility Criteria
- All patients covered under privacy laws (consent or waiver) known to have become pregnant following the ExAblate treatment for their Uterine Fibroids .
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Gina Hesley, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available