A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Menorrhagia
- Sponsor
- Ethicon, Inc.
- Enrollment
- 87
- Locations
- 11
- Primary Endpoint
- No Surgical Re-intervention
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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.
Investigators
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;
Outcomes
Primary Outcomes
No Surgical Re-intervention
Time Frame: Study completion
Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D\&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.
Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score
Time Frame: From baseline to 12 months
Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score.
Secondary Outcomes
- Maintenance of Menses(12 months)
- Decrease in Fibroid Bulk(From baseline to 12-months)
- Mean Improvement in Health Related Quality of Life (HRQOL) Scores(From baseline to 12 months)
- Procedural Satisfaction(12 months)
- Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores(From baseline to 12 months)