Clinical trial NCT01140555: A Pilot Study to Determine Optimal Procedure Steps to Obtain and Maintain Uterine Artery Occlusion With the D-UAO Device
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Fibroids
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-09
Enrollment: 2
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Optimal procedural steps
timeFrame: 6 hrs
Secondary outcomes:
measure: Fibroid devascularization
timeFrame: Baseline and 1 month post procedure
measure: Safety
timeFrame: Baseline through one month post procedure
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Allgemeines Krankenhaus, Abteilung für Gynäkologie und Geburtshilfe
city: Erlangen
country: Germany
facility: Frauenklinik, Universitatsklinikum Erlangen
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit medisch centrum (VU Medical Center), Dept of Obstetrics and Gynaecology
city: Oslo
country: Norway
facility: Ullevaal University Hospital, Department of Obstetrics & Gynaecology
Study officials:
affiliation: Ethicon, Inc.
name: David Robinson, M.D.
role: STUDY_DIRECTOR
References: