Clinical trial NCT00496080: Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding
Official title: A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Menorrhagia
Uterine Fibroids
Keywords: Menorrhagia associated with Uterine Fibroids
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 87
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: No Surgical Re-intervention
timeFrame: Study completion
measure: Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Mean Improvement in Health Related Quality of Life (HRQOL) Scores
timeFrame: From baseline to 12 months
measure: Maintenance of Menses
timeFrame: 12 months
measure: Procedural Satisfaction
timeFrame: 12 months
measure: Decrease in Fibroid Bulk
timeFrame: From baseline to 12-months
measure: Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Fort Lauderdale
country: United States
facility: Holy Cross Medical Group
state: Florida
city: Southfield
country: United States
facility: University Women's Care - Wayne State University
state: Michigan
city: Edina
country: United States
facility: Minnesota Gynecology and Surgery
state: Minnesota
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Chapel Hill
country: United States
facility: North Carolina Children's & Adults' Clinical Research Foundation
state: North Carolina
city: Columbus
country: United States
facility: Complete Healthcare for Women
state: Ohio
city: Philadelphia
country: United States
facility: Hahnemann University Hospital - Drexel University School of Med.
state: Pennsylvania
city: Arlington
country: United States
facility: Matlock Ob/Gyn
state: Texas
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
city: Monterrey
country: Mexico
facility: Hospital Universitario
state: Nuevo Leon
Study officials:
affiliation: Ethicon, Inc.
name: Piet Hinoul, M.D.
role: STUDY_DIRECTOR
References: