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

NCT ID: NCT01140555

Last Updated: 2011-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-07-31

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.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GYNECARE GYNOCCLUDE™

GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device

Group Type: EXPERIMENTAL

GYNECARE GYNOCCLUDE™

Intervention Type: DEVICE

GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device

Interventions

GYNECARE GYNOCCLUDE™

GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device

Intervention Type: DEVICE

Other Intervention Names

D-UAO Device

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Ethicon Inc.

Principal Investigators

David Robinson, M.D.

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

Allgemeines Krankenhaus, Abteilung für Gynäkologie und Geburtshilfe

Linz, , Austria

Frauenklinik, Universitatsklinikum Erlangen

Erlangen, , Germany

Vrije Universiteit medisch centrum (VU Medical Center), Dept of Obstetrics and Gynaecology

Amsterdam, , Netherlands

Ullevaal University Hospital, Department of Obstetrics & Gynaecology

Oslo, , Norway

Countries

Austria; Germany; Netherlands; Norway

Other Identifiers

300-09-007

Identifier Type: -

Identifier Source: org_study_id