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

NCT01140555 | Terminated

• 1 other identifier: 300-09-007
• Study Type: interventional
• Target: 2
• Locations: 4 countries
• Sites: 4

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.

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• Optimal procedural steps

  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

  6 hrs

Secondary Outcomes (2)

• Fibroid devascularization

  Baseline and 1 month post procedure

• Safety

  Baseline through one month post procedure

Study Arms (1)

GYNECARE GYNOCCLUDE™

EXPERIMENTAL

GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device

Device: GYNECARE GYNOCCLUDE™

Interventions

GYNECARE GYNOCCLUDE™ DEVICE

GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device

Also known as: D-UAO Device

GYNECARE GYNOCCLUDE™

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (4)

Allgemeines Krankenhaus, Abteilung für Gynäkologie und Geburtshilfe

Linz, A-4020, Austria

Location

Frauenklinik, Universitatsklinikum Erlangen

Erlangen, 91054, Germany

Location

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

Amsterdam, 1081 HV, Netherlands

Location

Ullevaal University Hospital, Department of Obstetrics & Gynaecology

Oslo, N-0407, Norway

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• David Robinson, M.D.

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 9, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 17, 2011

Record last verified: 2011-02

Locations

NO (1); AU (1); NL (1); DE (1)