Uterine Balloon Treatment for Heavy Period Bleeding.

Menorrhagia Clinical Trial

Official title:

Clinical Evaluation of Uterine Balloon Therapy System for Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215618
• Other study ID #: 2003-010
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2005
• Last updated: January 13, 2009
• Start date: March 2003
• Est. completion date: September 2008

Study information

• Verified date: January 2009
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This study was also designed to determine the effect of a post procedure curettage on bleeding patterns and post-operative discharge and pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 2008
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Device:
• Uterine Balloon Therapy
UBT with post procedure curettage
• Uterine Balloon Therapy
UBT without post procedure curettage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy.		6 and 12 mo	No
Secondary	Post-procedure bleeding levels		2 and 3 yrs	No
Secondary	Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain.		2 and 3 yrs	No
Secondary	System utility as indicated by equipment events that require intervention.		perioperative	No