MenorrhagiaNCT00496067
Uterine Artery Occlusion for Fibroid Related Bleeding
A study testing Doppler-Guided Uterine Artery Occlusion Device in people with Menorrhagia and Uterine Fibroids, run by Ethicon, Inc. at 14 sites in 7 countries.
Trial summary
The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 14 sitesin 7 countries
- Study dates
- Apr 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject has a negative urine or blood pregnancy test prior to the procedure. At the time of enrollment to the study, the subject has no intent of further childbearing and intends to use appropriate contraception throughout the first 12 months of the study period (unless sterilized)
- Normal pap smear within 36 months of study procedure (most recent)
- Cervix suitable for tenaculum placement as determined by pelvic exam (adequate length of cervix, absence of cervical fibroid/lower fibroid to prevent clamp placement)
- At least one intra-mural or sub-serosal or sub-mucosal uterine fibroid with a minimum diameter of greater than or equal to 3 cm, and all fibroids with a diameter less than or equal to 8cm with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound
- Symptomatic subject presenting with at least one of the following fibroid symptoms: pelvic pressure, menorrhagia, metrorrhagia, pelvic pain, increasing abdominal girth or dyspareunia due to fibroids.
- Subject has evidence of bilateral ureteric flow
- Subject agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Ethics Committee-approved informed consent.
Who cannot join
- Pregnancy as confirmed by positive urine or blood pregnancy test
- Menopausal as defined by elevated follicle-stimulating hormone (FSH) and decreased oestradiol hormone levels as determined by the hospital local laboratory reference range criteria
- Presence of any pedunculated sub-mucosal or pedunculated sub-serosal fibroid(s) as determined by MRI, ultrasound or hysteroscopy
- Presence of an intra-uterine device (IUD)
- Any hydronephrosis as determined on renal ultrasound prior to the procedure
- Clinical history of any thrombo-embolic disease or known thrombophilia
Show all 15Show fewer
- Blood Urine Nitrogen (BUN) greater than 7.2mmol/L* and/or serum creatinine greater than 106μmol/L* unresolved with change in diet or hydration
- History or current evidence of gynecologic malignancy (confirmed by hysteroscopy or endometrial biopsy), atypical endometrial hyperplasia, or chronic pelvic inflammatory disease
- Pelvic mass outside the uterus other than uterine fibroids
- Any current acute or chronic systemic infection or localized pelvic infection, including a urinary tract infection
- Use of Gonadotropin-Releasing Hormone (GnRH) agonist, danozol or mifepristone within 6-months prior to the start of the study procedure
- Using anticoagulation therapy (except over the counter treatments (e.g. aspirin)), or have an underlying bleeding disorder
- Unsuitable for MRI examination (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);
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
France4 sites
University Hospital
Angers, 49033
Service de Gynecologie Obsterique, Hopital Antoine Beclere
Clamart, 92414
Maternite les Bazennes
Dunkirk, 59430
CHRU de Lille, Hopital Jeanne de Flandre
Lille, 59037
United Kingdom4 sites
M1 Maternity, Bradford Royal Infirmary
Bradford, BD9 6RJ
Hull and East Yorkshire Women & Children Hospital
Hull, HU3 2JZ
Elizabeth Garret Anderson Hospital
London, WC1E 6DH
Queen Elizabeth the Queen Mother Hospital
Margate, CT9 4AN
Germany2 sites
Universitaeklinikum Erlangen
Erlangen, 91054
Universitats-Frauenklinik Tubingen
Tübingen, 72076
About this study
Official title: An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device as Treatment for the Reduction of Fibroid-Associated Bleeding
The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.
Read the detailed description
DUAO is intended for bilateral occlusion of the uterine arteries
- Conditions
- Menorrhagia, Uterine Fibroids
- Being tested
- Doppler-Guided Uterine Artery Occlusion Device
- Keywords
- Fibroids, Menorrhagia, 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 DeviceDevice
Also called floSTAT
For bilateral occlusion of the uterine arteries
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DUAO Device Receives: Device: Doppler-Guided Uterine Artery Occlusion Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lack of surgical re-intervention
Measured: Post-op through end of study
Secondary outcomes (13)
Percentage of subjects with improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity and Health Related Quality of Life (HRQL) scores.
Measured: 6, 12 and 24 months
Mean improvement in UFS-QOL Symptom Severity and HRQL transformed scores.
Measured: 6, 12 and 24 months
Mean HRQL subscales.
Measured: 6, 12 and 24 months
Percentage of subjects with reduction of 50% or greater in Pictorial Blood Loss Assessment Chart (PBLAC) score.
Measured: 6 and 12 months
Mean change in PBLAC scores.
Measured: Baseline to 6 and 12 months
Percentage of subjects with decrease in fibroid load based on independent MRI review.
Measured: 6 months
Percentage of subjects with maintenance of menses as defined by continuation of menstrual cycles without an interruption of three consecutive months
Measured: 12 months
Percentage of subjects with procedural satisfaction as defined by responses of either satisfied or very satisfied.
Measured: 12 months
Lack of surgical re-intervention.
Measured: 24 months
Pain score
Measured: Discharge or 24-hour post clamp removal, whichever is earlier
Days to normal activities (household, work and sexual intercourse)
Measured: Post procedure
Euro-QOL expressed as change from baseline for each of the 6 domains and Visual Analogue Scale (VAS)
Measured: 1, 3, 6 and 12 months
Nights in hospital
Measured: Total and post procedure
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 startApr 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Data required further pilot work to be undertaken.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Robinson, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496067
- Sponsor's protocol ID
- 300-06-008
- Status last verified
- Mar 2011
- First submitted
- 3 Jul 2007
- Last updated
- 9 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device as Treatment for the Reduction of Fibroid-Associated Bleeding
- ClinicalTrials.gov ID
- NCT00496067
- Acronym / sponsor ID
- 300-06-008
- Conditions
- Menorrhagia, Uterine Fibroids
- Keywords
- Fibroids, Menorrhagia, Menorrhagia associated with uterine fibroids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data required further pilot work to be undertaken.
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.
Detailed description
DUAO is intended for bilateral occlusion of the uterine arteries
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Doppler-Guided Uterine Artery Occlusion DeviceDUAO Device |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 25 to 50 years of age
- Subject has a negative urine or blood pregnancy test prior to the procedure. At the time of enrollment to the study, the subject has no intent of further childbearing and intends to use appropriate contraception throughout the first 12 months of the study period (unless sterilized)
- Normal pap smear within 36 months of study procedure (most recent)
- Cervix suitable for tenaculum placement as determined by pelvic exam (adequate length of cervix, absence of cervical fibroid/lower fibroid to prevent clamp placement)
- At least one intra-mural or sub-serosal or sub-mucosal uterine fibroid with a minimum diameter of greater than or equal to 3 cm, and all fibroids with a diameter less than or equal to 8cm with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound
Key exclusion criteria (15 listed)
- Pregnancy as confirmed by positive urine or blood pregnancy test
- Menopausal as defined by elevated follicle-stimulating hormone (FSH) and decreased oestradiol hormone levels as determined by the hospital local laboratory reference range criteria
- Presence of any pedunculated sub-mucosal or pedunculated sub-serosal fibroid(s) as determined by MRI, ultrasound or hysteroscopy
- Presence of an intra-uterine device (IUD)
- Any hydronephrosis as determined on renal ultrasound prior to the procedure
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 DeviceAlso: floSTATFor bilateral occlusion of the uterine arteries | Device | 1 |
Primary outcome
Lack of surgical re-intervention
Time frame: Post-op through end of study
13 secondary outcomes
Percentage of subjects with improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity and Health Related Quality of Life (HRQL) scores.
Time frame: 6, 12 and 24 months
Mean improvement in UFS-QOL Symptom Severity and HRQL transformed scores.
Time frame: 6, 12 and 24 months
Mean HRQL subscales.
Time frame: 6, 12 and 24 months
Percentage of subjects with reduction of 50% or greater in Pictorial Blood Loss Assessment Chart (PBLAC) score.
Time frame: 6 and 12 months
Mean change in PBLAC scores.
Time frame: Baseline to 6 and 12 months
Percentage of subjects with decrease in fibroid load based on independent MRI review.
Time frame: 6 months
Percentage of subjects with maintenance of menses as defined by continuation of menstrual cycles without an interruption of three consecutive months
Time frame: 12 months
Percentage of subjects with procedural satisfaction as defined by responses of either satisfied or very satisfied.
Time frame: 12 months
Lack of surgical re-intervention.
Time frame: 24 months
Pain score
Time frame: Discharge or 24-hour post clamp removal, whichever is earlier
Days to normal activities (household, work and sexual intercourse)
Time frame: Post procedure
Euro-QOL expressed as change from baseline for each of the 6 domains and Visual Analogue Scale (VAS)
Time frame: 1, 3, 6 and 12 months
Nights in hospital
Time frame: Total and post procedure
Results and safety
The study was stopped early (reason given: Data required further pilot work to be undertaken.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2011.
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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.
David Robinson, MD study director
Ethicon, Inc.
14 sites in 7 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 in people with Menorrhagia and Uterine Fibroids, run by Ethicon, Inc. at 14 sites in 7 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 8 inclusion and 15 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 9 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, United Kingdom, Germany, Denmark, Netherlands and 2 more countries. 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?
The study was stopped early (reason given: Data required further pilot work to be undertaken.). Results are not available in the source record.
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?
Lack of surgical re-intervention (time frame: Post-op through end of study). 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 9 Mar 2011.