Uterine FibroidsNCT01140555
A Pilot Study to Determine Optimal Procedure Steps to Obtain and Maintain Uterine Artery Occlusion With the D-UAO Device
A study testing GYNECARE GYNOCCLUDE™ in people with Uterine Fibroids, run by Ethicon, Inc. at 4 sites in 4 countries.
Trial summary
This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of multiple surgeons. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- GYNECARE GYNOCCLUDE™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Apr 2010to Jul 2010
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 25-55 years with regular menses and at least one symptom related to uterine fibroids (for example heavy bleeding).
- Completed child-bearing.
- 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 abdominal/transvaginal ultrasound.
- Confirmation of the ability to clearly visualise bilateral uterine arteries with 2/3DPD.
- Dominant fibroid (defined as >3cm in diameter) must be well vascularised as determined by CE-MRI (for Group 2 and 3 patients only).
- Able to tolerate the required prolonged supine position during treatment (approximately 6 hours).
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- Cervix suitable for tenaculum placement as determined by pelvic exam.
- Normal Pap smear within the last 36 months.
- Agrees to participate in the study, and following review of the patient information sheet documents this agreement by signing the Ethics Committee approved informed consent.
Who cannot join
- Prior endometrial ablation, uterine artery embolization, or uterine artery ligation.
- Pregnancy (As confirmed by a urine pregnancy test at screening and immediately prior to procedure).
- One or more lower uterine segment fibroids determined through pelvic exam which in the examiner's opinion would prevent proper clamp application.
- Any known contraindications to the contrast agent to be used for the CE-MRI as determined by the study radiologist (for Group 2 and 3 patients only).
- Pelvic mass outside the uterus suggesting other disease processes.
- An intrauterine device (IUD) in place during the day of procedure.
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- Hydronephrosis as determined by interpretation of a pre-procedure renal ultrasound.
- No ureteral jets observed on ultrasound prior to clamping.
- Presence of a pedunculated fibroid determined by ultrasound, hysteroscopy, or saline infused sonography or CE MRI.
- Any current acute or chronic systemic infection or localized pelvic infection, including an unresolved urinary tract infection.
- Clinical history of any thromboembolic disease.
- History of gynecologic malignancy, atypical endometrial hyperplasia, or pelvic inflammatory disease.
- Using anticoagulation therapy (except OTC treatments, e.g. aspirin), or has a known underlying bleeding disorder.
- In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Austria1 site
Allgemeines Krankenhaus, Abteilung für Gynäkologie und Geburtshilfe
Linz, A-4020
Netherlands1 site
Vrije Universiteit medisch centrum (VU Medical Center), Dept of Obstetrics and Gynaecology
Amsterdam, 1081 HV
Norway1 site
Ullevaal University Hospital, Department of Obstetrics & Gynaecology
Oslo, N-0407
About this study
Official title: A Pilot Study to Determine the Optimal Procedure Steps to Obtain and Maintain Bilateral Uterine Artery Occlusion Using the GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device in Women With Uterine Fibroids
This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of multiple surgeons.
Read the detailed description
- Group 1 - beginning with the use of the current instructions for use (IFU) will have adjustments made as necessary to the D-UAO procedural steps for uterine artery occlusion confirmed by 2/3-D Power Colour Doppler ultrasound (2/3DPD).
- Group 2 - verify that optimal D-UAO IFU procedural steps generated in Group 1 as confirmed by 2/3DPD.
- Group 3 - verify that the optimal D-UAO procedural steps are reproducible in the hands of multiple surgeons in addition to the group 1 investigators, as confirmed by 2/3DPD.
- Conditions
- Uterine Fibroids
- Being tested
- GYNECARE GYNOCCLUDE™
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GYNECARE GYNOCCLUDE™Device
Also called D-UAO Device
GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device
| Study group | Role | What they receive |
|---|---|---|
| GYNECARE GYNOCCLUDE™ | Experimental | GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device Receives: Device: GYNECARE GYNOCCLUDE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal procedural steps
Establish and verify optimal procedural steps to obtain and maintain bilateral uterine artery occlusion using the GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device (D-UAO) for 6 hours, and confirm that these optimal procedural steps are reproducible by multiple surgeons
Measured: 6 hrs
Secondary outcomes (2)
Fibroid devascularization
Evaluation of the actual and percentage change in the uterine volume, dominant fibroid volume, T2 frequency, contrast enhancement index in the dominant fibroid and the number of patient with complete infarction of all fibroid tissue obtained from a comparison of the baseline and 1 month contrast enhanced MRIs.
Measured: Baseline and 1 month post procedure
Safety
Incidence of patients with adverse events that result in the following: ureteral stenting, intra-operative or post operative blood transfusion, device related hospitalization >24hours, interventional treatment for fibroids within 1 month of the D-UAO procedure, DVT or PE, life threatening cardiac or respiratory arrest or other life threatening events
Measured: Baseline through one month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJul 2010
Why it stopped: Further internal evaluation of the device was required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Robinson, M.D., Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140555
- Sponsor's protocol ID
- 300-09-007
- Status last verified
- Feb 2011
- First submitted
- 8 Jun 2010
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Optimal Procedure Steps to Obtain and Maintain Bilateral Uterine Artery Occlusion Using the GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device in Women With Uterine Fibroids
- ClinicalTrials.gov ID
- NCT01140555
- Acronym / sponsor ID
- 300-09-007
- Conditions
- Uterine Fibroids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Further internal evaluation of the device was required.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Jun 2010 (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.
This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of multiple surgeons.
Detailed description
- Group 1 - beginning with the use of the current instructions for use (IFU) will have adjustments made as necessary to the D-UAO procedural steps for uterine artery occlusion confirmed by 2/3-D Power Colour Doppler ultrasound (2/3DPD).
- Group 2 - verify that optimal D-UAO IFU procedural steps generated in Group 1 as confirmed by 2/3DPD.
- Group 3 - verify that the optimal D-UAO procedural steps are reproducible in the hands of multiple surgeons in addition to the group 1 investigators, as confirmed by 2/3DPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GYNECARE GYNOCCLUDE™ | Experimental | Device: GYNECARE GYNOCCLUDE™GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 25-55 years with regular menses and at least one symptom related to uterine fibroids (for example heavy bleeding).
- Completed child-bearing.
- 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 abdominal/transvaginal ultrasound.
- Confirmation of the ability to clearly visualise bilateral uterine arteries with 2/3DPD.
- Dominant fibroid (defined as >3cm in diameter) must be well vascularised as determined by CE-MRI (for Group 2 and 3 patients only).
Key exclusion criteria (14 listed)
- Prior endometrial ablation, uterine artery embolization, or uterine artery ligation.
- Pregnancy (As confirmed by a urine pregnancy test at screening and immediately prior to procedure).
- One or more lower uterine segment fibroids determined through pelvic exam which in the examiner's opinion would prevent proper clamp application.
- Any known contraindications to the contrast agent to be used for the CE-MRI as determined by the study radiologist (for Group 2 and 3 patients only).
- Pelvic mass outside the uterus suggesting other disease processes.
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 |
|---|---|---|
| GYNECARE GYNOCCLUDE™Also: D-UAO DeviceGYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device | Device | GYNECARE GYNOCCLUDE™ |
Primary outcome
Optimal procedural steps
Time frame: 6 hrs
Establish and verify optimal procedural steps to obtain and maintain bilateral uterine artery occlusion using the GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device (D-UAO) for 6 hours, and confirm that these optimal procedural steps are reproducible by multiple surgeons
2 secondary outcomes
Fibroid devascularization
Time frame: Baseline and 1 month post procedure
Safety
Time frame: Baseline through one month post procedure
Results and safety
The study was stopped early (reason given: Further internal evaluation of the device was required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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, M.D. study director
Ethicon, Inc.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GYNECARE GYNOCCLUDE™ in people with Uterine Fibroids, run by Ethicon, Inc. at 4 sites in 4 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 9 inclusion and 14 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 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Germany, Netherlands, Norway. 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: Further internal evaluation of the device was required.). 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?
Optimal procedural steps (time frame: 6 hrs). 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 17 Feb 2011; AzTrials last refreshed its copy on 30 Oct 2026.