Status:
TERMINATED
A Pilot Study to Determine Optimal Procedure Steps to Obtain and Maintain Uterine Artery Occlusion With the D-UAO Device
Lead Sponsor:
Ethicon, Inc.
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
25-55 years
Phase:
NA
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...
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 Powe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01140555
Start Date
April 1 2010
End Date
July 1 2010
Last Update
February 17 2011
Active Locations (4)
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1
Allgemeines Krankenhaus, Abteilung für Gynäkologie und Geburtshilfe
Linz, Austria, A-4020
2
Frauenklinik, Universitatsklinikum Erlangen
Erlangen, Germany, 91054
3
Vrije Universiteit medisch centrum (VU Medical Center), Dept of Obstetrics and Gynaecology
Amsterdam, Netherlands, 1081 HV
4
Ullevaal University Hospital, Department of Obstetrics & Gynaecology
Oslo, Norway, N-0407