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.
This study was also designed to determine the effect of a post procedure curettage on bleeding patterns and post-operative discharge and pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
UBT with post procedure curettage
UBT without post procedure curettage
Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy.
Time frame: 6 and 12 mo
Post-procedure bleeding levels
Time frame: 2 and 3 yrs
Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain.
Time frame: 2 and 3 yrs
System utility as indicated by equipment events that require intervention.
Time frame: perioperative
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