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Uterine Balloon Treatment for Heavy Period Bleeding.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215618
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 14, 2009
Information provided by:
Ethicon, Inc.

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.

Condition or disease Intervention/treatment Phase
Menorrhagia Device: Uterine Balloon Therapy Phase 3

Detailed Description:
This study was also designed to determine the effect of a post procedure curettage on bleeding patterns and post-operative discharge and pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Uterine Balloon Therapy System for Menorrhagia
Study Start Date : March 2003
Actual Primary Completion Date : August 2006
Actual Study Completion Date : September 2008

Arm Intervention/treatment
Experimental: 1
Uterine Balloon Therapy with post procedure curettage
Device: Uterine Balloon Therapy
UBT with post procedure curettage
Other Name: with post procedure curettage

Experimental: 2
Uterine Balloon Therapy without post-procedure curettage
Device: Uterine Balloon Therapy
UBT without post procedure curettage
Other Name: without post procedure curettage

Primary Outcome Measures :
  1. Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy. [ Time Frame: 6 and 12 mo ]

Secondary Outcome Measures :
  1. Post-procedure bleeding levels [ Time Frame: 2 and 3 yrs ]
  2. Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain. [ Time Frame: 2 and 3 yrs ]
  3. System utility as indicated by equipment events that require intervention. [ Time Frame: perioperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female at least 30 years of age who is premenopausal and for whom childbearing is complete.
  • Excessive menstrual bleeding documented by a diary score of at least 150.
  • Have documented 3 months failed medical therapy or either a) contraindicated for or b) refused medical therapy.
  • Have an anatomically normal uterine cavity sounding at least 4cm, but not greater than 12cm.
  • Have a normal pap smear and no unexplained abnormal pap smears within 1 year of the procedure.
  • Agree not to switch from hormonal to non-hormonal contraception or vice versa during or just prior to the study.
  • Agree to use reliable contraception throughout the study.
  • Freely agree to participate in the study, including all study related procedures and evaluations, and document this agreement by signing informed consent documentation.

Exclusion Criteria:

  • Active pelvic inflammatory disease (PID) or recurrent chronic PID.
  • Active genital or urinary tract infection at the time of the procedure.
  • History of malignancy of the reproductive system within 5 years of the procedure or have ever had malignancy of the endometrium.
  • Endometrial neoplasia, determined by endometrial biopsy taken within 6 months of procedure.
  • Cavity distorting submucous myoma(s) determined by preoperative hysterogram, hysteroscopy, or transvaginal sonography within 6 months of the procedure.
  • Previous endometrial ablation procedure.
  • Previous uterine surgeries (such as full thickness myomectomy, subserosal myomectomy, uterine reconstruction, or any surgery in which thinning of the uterine musculature could occur) except for low transverse caesarean section.
  • Pregnant or desirous of future pregnancy.
  • Taken endometrial suppression medication, except for oral contraceptives, within 3 months of the procedure.
  • Concurrent open or laparoscopic surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00215618

Sponsors and Collaborators
Ethicon, Inc.
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Principal Investigator: Charles T Cash, MD Oakwood Hospital and Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Robinson MD, Ethicon Inc Identifier: NCT00215618     History of Changes
Other Study ID Numbers: 2003-010
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
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Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Menstruation Disturbances