Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding
This study has been terminated.
(Trial terminated early due to results from a similar study.)
Sponsor:
Ethicon, Inc.
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00496080
First received: July 3, 2007
Last updated: September 6, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Menorrhagia Uterine Fibroids |
Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding |
Further study details as provided by Ethicon, Inc.:
Primary Outcome Measures:
- No Surgical Re-intervention [ Time Frame: Study completion ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 Outcome Measures:
- Mean Improvement in Health Related Quality of Life (HRQOL) Scores [ Time Frame: From baseline to 12 months ] [ Designated as safety issue: No ]Participants categorized as "better" in the total UFS-QOL questionnaire, indicating an overall improvement in health-related quality of life. On this scale, higher scores are indicative of better quality of life, with a maximum(best)score of 100 and a minimum (worst)score of 0. "Better" was defined as a change of +12 or more from baseline at 12 mo.
- Maintenance of Menses [ Time Frame: 12 months ] [ Designated as safety issue: No ]Number of participants with continuation of menstrual cycles without interruption for three consecutive months
- Procedural Satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]Number of participants with responses of either "satisfied" or "very satisfied" on a qualitative survey that ranged from "very dissatisfied" (worst) to "very satisfied" (best)
- Decrease in Fibroid Bulk [ Time Frame: From baseline to 12-months ] [ Designated as safety issue: No ]
Number of participants with a minimum 15% decrease in fibroid bulk based on independent magnetic resonance imaging (MRI) review from baseline at 12 mo.
Note: As per protocol, MRIs were planned only for subjects 1 - 40, 81 - 120, and 161-200.
- Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores [ Time Frame: From baseline to 12 months ] [ Designated as safety issue: No ]Number of participants categorized as "better" in the UFS-QOL sympton severity questionnaire, indicating an overall improvement in fibroid related symptoms. On this scale, higher scores are indicative of increasing symptom distress, with a maximum(worst)score of 100 and a minimum (best)score of 0. "Better" was defined as a change of -11 or less from baseline at 12 mo.
| Enrollment: | 87 |
| Study Start Date: | June 2007 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DUAO Device
Doppler-guided uterine artery occlusion device (Single-arm study)
|
Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)
Investigational transvaginal clamp inserted one time for 6 hours.
Other Name: floSTAT
|
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| Ages Eligible for Study: | 25 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496080
Locations
| United States, Arizona | |
| Women's Health Research | |
| Phoenix, Arizona, United States, 85015-2110 | |
| United States, Florida | |
| Holy Cross Medical Group | |
| Fort Lauderdale, Florida, United States, 33308 | |
| United States, Michigan | |
| University Women's Care - Wayne State University | |
| Southfield, Michigan, United States, 48034 | |
| United States, Minnesota | |
| Minnesota Gynecology and Surgery | |
| Edina, Minnesota, United States, 55435 | |
| United States, Missouri | |
| St. Luke's Hospital | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, North Carolina | |
| North Carolina Children's & Adults' Clinical Research Foundation | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Ohio | |
| Complete Healthcare for Women | |
| Columbus, Ohio, United States, 43231 | |
| United States, Pennsylvania | |
| Hahnemann University Hospital - Drexel University School of Med. | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| United States, Texas | |
| Matlock Ob/Gyn | |
| Arlington, Texas, United States, 76014 | |
| Canada, Ontario | |
| St. Joseph's Health Care | |
| London, Ontario, Canada, N6A 4V2 | |
| Mexico | |
| Hospital Universitario | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
Sponsors and Collaborators
Ethicon, Inc.
Investigators
| Study Director: | Piet Hinoul, M.D. | Ethicon, Inc. |
More Information
No publications provided
| Responsible Party: | Ethicon, Inc. |
| ClinicalTrials.gov Identifier: | NCT00496080 History of Changes |
| Other Study ID Numbers: | 300-06-004 |
| Study First Received: | July 3, 2007 |
| Results First Received: | June 19, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Mexico: Ministry of Health |
Keywords provided by Ethicon, Inc.:
|
Menorrhagia associated with Uterine Fibroids |
Additional relevant MeSH terms:
|
Hemorrhage Leiomyoma Myofibroma Menorrhagia Pathologic Processes Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Menstruation Disturbances |
ClinicalTrials.gov processed this record on May 16, 2013