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Uterine Balloon Treatment for Heavy Period Bleeding.

Sponsor
Ethicon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00215618
Collaborator
(none)
250
Enrollment
2
Arms
66.1
Duration (Months)

Study Details

Study Description

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
  • Device: Uterine Balloon Therapy
  • 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.

Study Design

Study Type:
Interventional
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 :
Mar 1, 2003
Actual Primary Completion Date :
Aug 1, 2006
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Uterine Balloon Therapy with post procedure curettage

Device: Uterine Balloon Therapy
UBT with post procedure curettage
Other Names:
  • with post procedure curettage

    		•
    Experimental: 2

    Uterine Balloon Therapy without post-procedure curettage

    Device: Uterine Balloon Therapy
    UBT without post procedure curettage
    Other Names:
  • without post procedure curettage

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy. [6 and 12 mo]

    Secondary Outcome Measures

    1. Post-procedure bleeding levels [2 and 3 yrs]

    2. Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain. [2 and 3 yrs]

    3. System utility as indicated by equipment events that require intervention. [perioperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ethicon, Inc.

    Investigators

    • Principal Investigator: Charles T Cash, MD, Oakwood Hospital and Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00215618
    Other Study ID Numbers:
    • 2003-010
    First Posted:
    Sep 22, 2005
    Last Update Posted:
    Jan 14, 2009
    Last Verified:
    Jan 1, 2009
    Additional relevant MeSH terms:
    Menorrhagia

    Study Results

    No Results Posted as of Jan 14, 2009