Uterine Balloon Treatment for Heavy Period Bleeding. - Full Text View

Sponsor:	Ethicon, Inc.
Information provided by:	Ethicon, Inc.
ClinicalTrials.gov Identifier:	NCT00215618

Purpose

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	Intervention	Phase
Menorrhagia	Device: Uterine Balloon Therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
Official Title:	Clinical Evaluation of Uterine Balloon Therapy System for Menorrhagia

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:

Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy. [ Time Frame: 6 and 12 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post-procedure bleeding levels [ Time Frame: 2 and 3 yrs ] [ Designated as safety issue: No ]
Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain. [ Time Frame: 2 and 3 yrs ] [ Designated as safety issue: No ]
System utility as indicated by equipment events that require intervention. [ Time Frame: perioperative ] [ Designated as safety issue: No ]

Enrollment:	250
Study Start Date:	March 2003
Study Completion Date:	September 2008
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Uterine Balloon Therapy with post procedure curettage	Device: Uterine Balloon Therapy UBT with post procedure curettage
2: Experimental Uterine Balloon Therapy without post-procedure curettage	Device: Uterine Balloon Therapy UBT without post procedure curettage

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215618

Sponsors and Collaborators

Ethicon, Inc.

Investigators

Principal Investigator:

Charles T Cash, MD

Oakwood Hospital & Medical Center

More Information

No publications provided

Responsible Party:	Ethicon Inc ( David Robinson MD )
Study ID Numbers:	2003-010
Study First Received:	September 19, 2005
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00215618 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Genital Diseases, Female
Pathologic Processes
Menorrhagia

Menstruation Disturbances
Uterine Hemorrhage
Uterine Diseases

ClinicalTrials.gov processed this record on November 20, 2009