Uterine Balloon Treatment for Heavy Period Bleeding.

January 13, 2009 updated by: Ethicon, Inc.

Clinical Evaluation of Uterine Balloon Therapy System for Menorrhagia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
Device: Uterine Balloon Therapy
UBT without post procedure curettage
Other Names:
  • without post procedure curettage
EXPERIMENTAL: 2
Uterine Balloon Therapy without post-procedure curettage
Device: Uterine Balloon Therapy
UBT with post procedure curettage
Other Names:
  • with post procedure curettage
Device: Uterine Balloon Therapy
UBT without post procedure curettage
Other Names:
  • without post procedure curettage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy.
Time Frame: 6 and 12 mo
6 and 12 mo

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-procedure bleeding levels
Time Frame: 2 and 3 yrs
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
2 and 3 yrs
System utility as indicated by equipment events that require intervention.
Time Frame: perioperative
perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (ACTUAL)

August 1, 2006

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2009

Last Update Submitted That Met QC Criteria

January 13, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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