Clinical Trial: Uterine Balloon Treatment for Heavy Period Bleeding.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Evaluation of Uterine Balloon Therapy System for Menorrhagia
Brief 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.
Detailed Summary: This study was also designed to determine the effect of a post procedure curettage on bleeding patterns and post-operative discharge and pain.
Sponsor: Ethicon, Inc.
Current Primary Outcome: Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy. [ Time Frame: 6 and 12 mo ]
Original Primary Outcome: Incidence of post-procedure amenorrhea in women treated with GYNECARE THERMACHOICE III.
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- Post-procedure bleeding levels
- Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain.
- System utility as indicated by equipment events that require intervention.
Information By: Ethicon, Inc.
Dates:
Date Received: September 19, 2005
Date Started: March 2003
Date Completion:
Last Updated: January 13, 2009
Last Verified: January 2009
