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A Pilot Study to Determine Optimal Procedure Steps to Obtain and Maintain Uterine Artery Occlusion With the D-UAO Device

This study has been terminated.
(Further internal evaluation of the device was required.)
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01140555
First received: June 8, 2010
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Uterine Fibroids
Device: GYNECARE GYNOCCLUDE™

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Optimal procedural steps [ Time Frame: 6 hrs ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Fibroid devascularization [ Time Frame: Baseline and 1 month post procedure ] [ Designated as safety issue: No ]
    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.

  • Safety [ Time Frame: Baseline through one month post procedure ] [ Designated as safety issue: Yes ]
    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


Enrollment: 2
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GYNECARE GYNOCCLUDE™
GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device
Device: GYNECARE GYNOCCLUDE™
GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device
Other Name: D-UAO Device

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

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140555

Locations
Austria
Allgemeines Krankenhaus, Abteilung für Gynäkologie und Geburtshilfe
Linz, Austria, A-4020
Germany
Frauenklinik, Universitatsklinikum Erlangen
Erlangen, Germany, 91054
Netherlands
Vrije Universiteit medisch centrum (VU Medical Center), Dept of Obstetrics and Gynaecology
Amsterdam, Netherlands, 1081 HV
Norway
Ullevaal University Hospital, Department of Obstetrics & Gynaecology
Oslo, Norway, N-0407
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: David Robinson, M.D. Ethicon, Inc.
  More Information

No publications provided

Responsible Party: David Robinson, M.D., Ethicon Inc.
ClinicalTrials.gov Identifier: NCT01140555     History of Changes
Other Study ID Numbers: 300-09-007
Study First Received: June 8, 2010
Last Updated: February 16, 2011
Health Authority: Austria: Federal Office for Safety in Health Care
Germany: German Institute of Medical Documentation and Information
Norway: Directorate of Health
Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Connective Tissue Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on November 20, 2014