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

Ethicon

Status

Terminated

Conditions

Uterine Fibroids

Menorrhagia

Treatments

Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00496080

300-06-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

87 patients

Sex

Female

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

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.