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Uterine Balloon Treatment for Heavy Period Bleeding.

Primary Purpose

Menorrhagia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Uterine Balloon Therapy
Uterine Balloon Therapy
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    Uterine Balloon Therapy with post procedure curettage

    Uterine Balloon Therapy without post-procedure curettage

    Outcomes

    Primary Outcome Measures

    Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 19, 2005
    Last Updated
    January 13, 2009
    Sponsor
    Ethicon, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00215618
    Brief Title
    Uterine Balloon Treatment for Heavy Period Bleeding.
    Official Title
    Clinical Evaluation of Uterine Balloon Therapy System for Menorrhagia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    September 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ethicon, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Menorrhagia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    250 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Uterine Balloon Therapy with post procedure curettage
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Uterine Balloon Therapy without post-procedure curettage
    Intervention Type
    Device
    Intervention Name(s)
    Uterine Balloon Therapy
    Other Intervention Name(s)
    with post procedure curettage
    Intervention Description
    UBT with post procedure curettage
    Intervention Type
    Device
    Intervention Name(s)
    Uterine Balloon Therapy
    Other Intervention Name(s)
    without post procedure curettage
    Intervention Description
    UBT without post procedure curettage
    Primary Outcome Measure Information:
    Title
    Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy.
    Time Frame
    6 and 12 mo
    Secondary Outcome Measure Information:
    Title
    Post-procedure bleeding levels
    Time Frame
    2 and 3 yrs
    Title
    Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain.
    Time Frame
    2 and 3 yrs
    Title
    System utility as indicated by equipment events that require intervention.
    Time Frame
    perioperative

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles T Cash, MD
    Organizational Affiliation
    Oakwood Hospital and Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22748952
    Citation
    Cash C Jr, Garza-Leal J, Donovan A, Guidry C, Romanowski C, Patel B. Clinical evaluation of long-term safety and effectiveness of a third-generation thermal uterine balloon therapy system for heavy menstrual bleeding. J Minim Invasive Gynecol. 2012 Jul-Aug;19(4):469-76. doi: 10.1016/j.jmig.2012.03.015.
    Results Reference
    derived

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