MenorrhagiaDUAONCT00496080
Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding
A study testing Doppler-Guided Uterine Artery Occlusion Device (DUAO) in people with Menorrhagia and Uterine Fibroids, run by Ethicon, Inc. at 11 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Menorrhagia, Uterine Fibroids
- What is being tested?
- Doppler-Guided Uterine Artery Occlusion Device (DUAO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Jun 2007to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States9 sites
Matlock Ob/Gyn
Arlington, Texas, 76014
North Carolina Children's & Adults' Clinical Research Foundation
Chapel Hill, North Carolina, 27514
St. Luke's Hospital
Chesterfield, Missouri, 63017
Complete Healthcare for Women
Columbus, Ohio, 43231
Minnesota Gynecology and Surgery
Edina, Minnesota, 55435
Holy Cross Medical Group
Fort Lauderdale, Florida, 33308
Hahnemann University Hospital - Drexel University School of Med.
Philadelphia, Pennsylvania, 19102
Women's Health Research
Phoenix, Arizona, 85015-2110
University Women's Care - Wayne State University
Southfield, Michigan, 48034
About this study
Official title: A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding
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.
Read the 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
- Being tested
- Doppler-Guided Uterine Artery Occlusion Device (DUAO)
- Keywords
- Menorrhagia associated with Uterine Fibroids
- Medical subject headings
- Menorrhagia, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler-Guided Uterine Artery Occlusion Device (DUAO)Device
Also called floSTAT
Investigational transvaginal clamp inserted one time for 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| DUAO Device | Experimental | Doppler-guided uterine artery occlusion device (Single-arm study) Receives: Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
No Surgical Re-intervention
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.
Measured: Study completion
Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score
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.
Measured: From baseline to 12 months
Secondary outcomes (5)
Mean Improvement in Health Related Quality of Life (HRQOL) Scores
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.
Measured: From baseline to 12 months
Maintenance of Menses
Number of participants with continuation of menstrual cycles without interruption for three consecutive months
Measured: 12 months
Procedural Satisfaction
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)
Measured: 12 months
Decrease in Fibroid Bulk
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.
Measured: From baseline to 12-months
Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores
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.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2010
- Study completionOct 2010
Why it stopped: Trial terminated early due to results from a similar study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piet Hinoul, M.D., Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496080
- Sponsor's protocol ID
- 300-06-004
- Acronym
- DUAO
- Status last verified
- Sep 2012
- First submitted
- 3 Jul 2007
- Last updated
- 10 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding
- ClinicalTrials.gov ID
- NCT00496080
- Acronym / sponsor ID
- DUAO / 300-06-004
- Conditions
- Menorrhagia, Uterine Fibroids
- Keywords
- Menorrhagia associated with Uterine Fibroids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated early due to results from a similar study.
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Posted 24 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DUAO Device | Experimental | Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)Doppler-guided uterine artery occlusion device (Single-arm study) |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler-Guided Uterine Artery Occlusion Device (DUAO)Also: floSTATInvestigational transvaginal clamp inserted one time for 6 hours. | Device | DUAO Device |
Primary outcome
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.
5 secondary outcomes
Mean Improvement in Health Related Quality of Life (HRQOL) Scores
Time frame: From baseline to 12 months
Maintenance of Menses
Time frame: 12 months
Procedural Satisfaction
Time frame: 12 months
Decrease in Fibroid Bulk
Time frame: From baseline to 12-months
Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores
Time frame: From baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piet Hinoul, M.D. study director
Ethicon, Inc.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler-Guided Uterine Artery Occlusion Device (DUAO) in people with Menorrhagia and Uterine Fibroids, run by Ethicon, Inc. at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No Surgical Re-intervention (time frame: Study completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.