Uterine Balloon Treatment for Heavy Period Bleeding. | NCT00215618

Studies
Uterine Balloon Treatment for Heavy Period Bleeding.

NCT00215618

Sponsor

Ethicon, Inc.

Status

Completed

Last Update Posted

Jan 14, 2009Estimated

Enrollment

250Actual

Phase

Phase 3

Conditions

Menorrhagia

Interventions

Uterine Balloon Therapy
Uterine Balloon Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Aug 2006Actual

Completion Date

Sep 2008Actual

First Submitted Date

Sep 19, 2005

First Submission Date that Met QC Criteria

Sep 19, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2009

Last Update Posted Date

Jan 14, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Uterine Balloon Therapy	Device	UBT with post procedure curettage	1

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

Measure	Description	Time Frame
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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Charles T Cash, MD	Oakwood Hospital and Medical Center	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22748952	Derived	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.

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases