Uterine Balloon Treatment for Heavy Period Bleeding.
NCT00215618 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2009-01-14
Summary
The purpose of this research is to determine the proportion of women who achieve permanent cessation of bleeding after Uterine Balloon Therapy (UBT) for the treatment of heavy uterine bleeding.
Conditions
- Menorrhagia
Interventions
- DEVICE
-
Uterine Balloon Therapy
UBT with post procedure curettage
- DEVICE
-
Uterine Balloon Therapy
UBT without post procedure curettage
Sponsors & Collaborators
-
Ethicon, Inc.
lead INDUSTRY
Principal Investigators
-
Charles T Cash, MD · Oakwood Hospital and Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-31
- Primary Completion
- 2006-08-31
- Completion
- 2008-09-30
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