TerminatedNCT00496080DUAOUpdated Sep 10, 2012Results posted

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

An interventional study of Doppler-Guided Uterine Artery Occlusion Device (DUAO) in Menorrhagia and Uterine Fibroids, sponsored by Ethicon, Inc.. Terminated at 11 sites in 3 countries. Open to female participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-09-10.

Sponsored by Ethicon, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated

Trial terminated early due to results from a similar study.

Phase: Not applicable
Study type: Interventional
Enrollment: 87
Allocation: Not applicable
Ages: 25 Years to 50 Years
Sex: Female

Study 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 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 studied

Menorrhagia
Uterine Fibroids

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Keywords

Menorrhagia associated with Uterine Fibroids

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's enrollment of 87 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years to 50 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 87 participants (actual)

Study arms

Experimental
DUAO Device
Doppler-guided uterine artery occlusion device (Single-arm study)
Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)

Interventions

DeviceDoppler-Guided Uterine Artery Occlusion Device (DUAO)
Investigational transvaginal clamp inserted one time for 6 hours.
Also known as: floSTAT

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: From baseline to 12 months

Secondary outcomes

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.
Time frame: From baseline to 12 months
Maintenance of Menses
Number of participants with continuation of menstrual cycles without interruption for three consecutive months
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 12 months

Results

Posted Jul 24, 2012

Limitations and caveats

Study was terminated early because 6 mo interim analysis of parallel European study showed that device was not meeting the primary endpoint. Target enrollment was 200 subjects, but results are based on 87 subjects who were treated with the device.

Participant flow

Recruitment took place from June 2007 through May 2009. Sites included hospitals, surgical centers and private practices in North America.

Participant flow — Overall Study
Milestone	DUAO Device
Started	87
Completed	60
Not completed	27
Withdrew: Lost to follow-up	9
Withdrew: Surgical re-intervention	7
Withdrew: Withdrawal by subject	5
Withdrew: Physician decision	6

Outcome measures

PrimaryNo 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.

Time frame:: Study completion
Reported as:: Number · participants

No Surgical Re-intervention
participants	DUAO Device
No Surgical Re-intervention	74 (82.7 to 95.9)

PrimaryImprovement 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.

Time frame:: From baseline to 12 months
Reported as:: Number · participants

Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score
participants	DUAO Device
Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score	15 (12.7 to 33.3)

SecondaryMean 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.

Time frame:: From baseline to 12 months
Reported as:: Number · participants

Mean Improvement in Health Related Quality of Life (HRQOL) Scores
participants	DUAO Device
Mean Improvement in Health Related Quality of Life (HRQOL) Scores	54

SecondaryMaintenance of Menses

Number of participants with continuation of menstrual cycles without interruption for three consecutive months

Time frame:: 12 months
Reported as:: Number · participants

Maintenance of Menses
participants	DUAO Device
Maintenance of Menses	53

SecondaryProcedural 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)

Time frame:: 12 months
Reported as:: Number · participants

Procedural Satisfaction
participants	DUAO Device
Undecided	11
Very Dissatisfied	2
Dissatisfied	5
Satisfied	21
Very Satisfied	29

SecondaryDecrease 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.

Time frame:: From baseline to 12-months
Reported as:: Number · participants

Decrease in Fibroid Bulk
participants	DUAO Device
Decrease in Fibroid Bulk	10

SecondaryMean 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.

Time frame:: From baseline to 12 months
Reported as:: Number · participants

Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores
participants	DUAO Device
Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores	55

Adverse events

Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
DUAO Device	—	4/87 (4.6%)	37/87 (42.5%)

Most frequent serious events

Most frequent serious events
Event	DUAO Device
Urinary RetentionRenal and urinary disorders	2/87
DiverticulitisInfections and infestations	1/87
Medication ErrorInjury, poisoning and procedural complications	1/87
Dysfunctional uterine bleedingReproductive system and breast disorders	1/87

Most frequent other events

Most frequent other events
Event	DUAO Device
NauseaGastrointestinal disorders	10/87
Pelvic painInjury, poisoning and procedural complications	10/87
HydronephrosisRenal and urinary disorders	9/87
Vaginal DischargeReproductive system and breast disorders	9/87
HeadacheNervous system disorders	7/87
Back PainMusculoskeletal and connective tissue disorders	6/87
DysmenorrheaReproductive system and breast disorders	6/87
Procedural painInjury, poisoning and procedural complications	5/87

Baseline characteristics

Age Continuous
Age Continuous(years)	DUAO Device
Mean	42.3 ± 4.9

Sex: Female, Male
Sex: Female, Male(Participants)	DUAO Device
Female	87
Male	0

Region of Enrollment
Region of Enrollment(participants)	DUAO Device
United States	48
Mexico	30
Canada	9

Study locations

11 sites

Women's Health Research
Phoenix, Arizona 85015-2110, United States
Holy Cross Medical Group
Fort Lauderdale, Florida 33308, United States
University Women's Care - Wayne State University
Southfield, Michigan 48034, United States
Minnesota Gynecology and Surgery
Edina, Minnesota 55435, United States
St. Luke's Hospital
Chesterfield, Missouri 63017, United States
North Carolina Children's & Adults' Clinical Research Foundation
Chapel Hill, North Carolina 27514, United States
Complete Healthcare for Women
Columbus, Ohio 43231, United States
Hahnemann University Hospital - Drexel University School of Med.
Philadelphia, Pennsylvania 19102, United States
Matlock Ob/Gyn
Arlington, Texas 76014, United States
St. Joseph's Health Care
London, Ontario N6A 4V2, Canada
Hospital Universitario
Monterrey, Nuevo Leon 64460, Mexico

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00496080
Lead sponsor: Ethicon, Inc.
Responsible party: Sponsor
First posted: Jul 4, 2007
Start date: Jun 2007
Primary completion: Sep 2010
Completion: Oct 2010
Results posted: Jul 24, 2012
Last update: Sep 10, 2012

Study contacts

Piet Hinoul, M.D.

study director · Ethicon, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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