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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


N/A
25 Years
55 Years
Not Enrolling
Female
Uterine Fibroids

Thank you

Trial Information

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


1. 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).

2. Group 2 - verify that optimal D-UAO IFU procedural steps generated in Group 1 as
confirmed by 2/3DPD.

3. 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.


Inclusion Criteria:



- 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).

- 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.

Exclusion Criteria:

- 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.

- 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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Optimal procedural steps

Outcome Description:

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

Outcome Time Frame:

6 hrs

Safety Issue:

No

Principal Investigator

David Robinson, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ethicon, Inc.

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

300-09-007

NCT ID:

NCT01140555

Start Date:

April 2010

Completion Date:

July 2010

Related Keywords:

  • Uterine Fibroids
  • Leiomyoma
  • Myofibroma
  • Arterial Occlusive Diseases

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