Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding

NCT ID: NCT00496080

Last Updated: 2012-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-10-31

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.

Detailed Description

The GYNECARE GYNOCCLUDE D-UAO Instruments are single-use disposable instruments consisting of a GYNECARE GYNOCCLUDE Uterine Stabilizer, a GYNECARE GYNOCCLUDEM Introducer Sheath, a GYNECARE GYNOCCLUDE Doppler Clamp, and a GYNECARE GYNOCCLUDE Coupler.

Conditions

Menorrhagia; Uterine Fibroids

Keywords

Menorrhagia associated with Uterine Fibroids

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DUAO Device

Doppler-guided uterine artery occlusion device (Single-arm study)

Group Type: EXPERIMENTAL

Doppler-Guided Uterine Artery Occlusion Device (DUAO)

Intervention Type: DEVICE

Investigational transvaginal clamp inserted one time for 6 hours.

Interventions

Doppler-Guided Uterine Artery Occlusion Device (DUAO)

Investigational transvaginal clamp inserted one time for 6 hours.

Intervention Type: DEVICE

Other Intervention Names

floSTAT

Eligibility Criteria

Inclusion Criteria

• 25 to 50 years of age;
• PBLAC score of 150 or greater;
• Completed child-bearing;
• Normal Pap smear within 12 months;
• Cervix suitable for tenaculum placement as determined by pelvic exam;
• At least one uterine fibroid of 3 cm diameter or greater with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound;
• Willing to maintain use or non-use of hormonal contraception from 3 months pre-study throughout the 12-month follow-up period;
• Willing to maintain use or non-use of anti-fibrinolytic agents from 3 months pre-study throughout the 12-month follow-up period;
• Able to tolerate the required prolonged supine position during treatment (approximately 6 hours);
• Willing and able to provide informed consent and to follow study-related requirements;

Exclusion Criteria

• Pregnancy (as confirmed immediately prior to procedure)
• Fibroid diameter greater than 8.0 cm determined through transvaginal ultrasound; [or if 2 dimensions are measured, total dimension greater than 16 cm; or if the 3 dimensions (length, height, width) are measured, total dimension greater than 24 cm];
• Presence of a pedunculated fibroid determined by ultrasound; hysteroscopy, or saline infused sonography;
• Hydronephrosis as determined by radiologist interpretation on renal ultrasound pre-procedurally;
• Menopausal;
• Clinical history of any thromboembolic disease;
• Blood urine nitrogen (BUN) greater than 20 mg/dL and/or serum creatinine greater than 1.2 mg/dL unresolved with change in diet or hydration; · One or more lower uterine segment fibroids determined through pelvic exam;
• History of gynecologic malignancy, atypical endometrial hyperplasia, or pelvic inflammatory disease;
• Abnormal endometrial biopsy within the last 6 months prior to procedure;
• Pelvic mass outside the uterus suggesting other disease processes;
• Any current acute or chronic systemic infection or localized pelvic infection, including an unresolved urinary tract infection;
• Using GnRH agonist or mifepristone within 6-months prior to the start of the study;
• An intrauterine device (IUD) in place;
• Using anticoagulation therapy (except OTC treatments (e.g. aspirin)), or have an underlying bleeding disorder;
• Unsuitable for MRI examination, if within study subgroup to undergo MRI evaluation (e.g. severe claustrophobia, non-MRI-compatible implanted metalloid devices);
• Prior endometrial ablation, uterine artery embolization, or uterine artery ligation;
• Poor procedural candidate due to medical conditions as determined by the investigator (e.g. anesthesia class, renal insufficiency, heart disease);
• Grade 1 for 3D Color Doppler or no flow observed for cystoscopy on ureter flow assessment if applicable.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piet Hinoul, M.D.

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

Women's Health Research

Phoenix, Arizona, United States

Holy Cross Medical Group

Fort Lauderdale, Florida, United States

University Women's Care - Wayne State University

Southfield, Michigan, United States

Minnesota Gynecology and Surgery

Edina, Minnesota, United States

St. Luke's Hospital

Chesterfield, Missouri, United States

North Carolina Children's & Adults' Clinical Research Foundation

Chapel Hill, North Carolina, United States

Complete Healthcare for Women

Columbus, Ohio, United States

Hahnemann University Hospital - Drexel University School of Med.

Philadelphia, Pennsylvania, United States

Matlock Ob/Gyn

Arlington, Texas, United States

St. Joseph's Health Care

London, Ontario, Canada

Hospital Universitario

Monterrey, Nuevo León, Mexico

Countries

United States; Canada; Mexico

Other Identifiers

300-06-004

Identifier Type: -

Identifier Source: org_study_id