NCT00215618

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

3.4 years

First QC Date

September 19, 2005

Last Update Submit

January 13, 2009

Conditions

Menorrhagia

Outcome Measures

Primary Outcomes (1)

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

    6 and 12 mo

Secondary Outcomes (3)

  • Post-procedure bleeding levels

    2 and 3 yrs

  • Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain.

    2 and 3 yrs

  • System utility as indicated by equipment events that require intervention.

    perioperative

Study Arms (2)

1

EXPERIMENTAL

Uterine Balloon Therapy with post procedure curettage

Device: Uterine Balloon Therapy

2

EXPERIMENTAL

Uterine Balloon Therapy without post-procedure curettage

Device: Uterine Balloon Therapy

Interventions

Uterine Balloon TherapyDEVICE

UBT with post procedure curettage

Also known as: with post procedure curettage
1

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22748952DERIVED

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Officials

  • Charles T Cash, MD

    Oakwood Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

March 1, 2003

Primary Completion

August 1, 2006

Study Completion

September 1, 2008

Last Updated

January 14, 2009

Record last verified: 2009-01