Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Ethicon, Inc. |
---|---|
Information provided by: | Ethicon, Inc. |
ClinicalTrials.gov Identifier: | NCT00496067 |
The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.
Condition | Intervention |
---|---|
Menorrhagia Uterine Fibroids |
Device: Doppler-Guided Uterine Artery Occlusion Device |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device as Treatment for the Reduction of Fibroid-Associated Bleeding |
Estimated Enrollment: | 100 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
DUAO Device
|
Device: Doppler-Guided Uterine Artery Occlusion Device
For bilateral occlusion of the uterine arteries
|
DUAO is intended for bilateral occlusion of the uterine arteries
Ages Eligible for Study: | 25 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Judi Gauld, BSc (Hons) | +44 150 659 4679 | jgauld@its.jnj.com |
Denmark | |
Viborg County Hospital | Recruiting |
Viborg, Denmark, DK-8800 | |
France | |
Service de Gynecologie Obsterique, Hopital Antoine Beclere | Recruiting |
Clamart Cedex, France, 92414 | |
University Hospital | Recruiting |
Angers cedex, France, 49033 | |
Maternite les Bazennes | Recruiting |
Dunkerque, France, 59430 | |
Hopital Nord | Withdrawn |
Marseille Cedex 15, France, 13015 | |
CHRU de Lille, Hopital Jeanne de Flandre | Recruiting |
Lille Cedex, France, 59037 | |
Principal Investigator: Jean-Philippe Lucot, MD | |
Germany | |
Universitaeklinikum Erlangen | Recruiting |
Erlangen, Germany, 91054 | |
Universitats-Frauenklinik Tubingen | Recruiting |
Tubingen, Germany, 72076 | |
Netherlands | |
VU Medical Center | Recruiting |
Amsterdam, Netherlands, 1081 HV | |
Norway | |
Ullevaal University | Recruiting |
Oslo, Norway, N-0407 | |
Switzerland | |
Universitats-Frauenklinik | Recruiting |
Bern, Switzerland, 3012 | |
United Kingdom | |
Hull and East Yorkshire Women & Children Hospital | Recruiting |
Hull, United Kingdom, HU3 2JZ | |
Principal Investigator: Steve Killick, MD | |
Elizabeth Garret Anderson Hospital | Not yet recruiting |
London, United Kingdom, WC1E 6DH | |
M1 Maternity, Bradford Royal Infirmary | Recruiting |
Bradford, United Kingdom, BD9 6RJ | |
Queen Elizabeth the Queen Mother Hospital | Recruiting |
Margate, United Kingdom, CT9 4AN |
Study Director: | David Robinson, MD | Ethicon, Inc. |
Responsible Party: | Ethicon Inc. ( Judi Gauld, Manager Clinical Research ) |
Study ID Numbers: | 300-06-008 |
Study First Received: | July 3, 2007 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00496067 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: German Institute of Medical Documentation and Information; France: Afssaps - French Health Products Safety Agency; Switzerland: Swissmedic; Norway: Directorate for Health and Social Affairs; Denmark: Danish Medicines Agency; Netherlands: Dutch Health Care Inspectorate |
Fibroids Menorrhagia Menorrhagia associated with uterine fibroids |
Genital Diseases, Female Neoplasms, Connective and Soft Tissue Myofibroma Menstruation Disturbances Uterine Hemorrhage |
Connective Tissue Diseases Uterine Diseases Menorrhagia Hemorrhage Leiomyoma |
Neoplasms, Muscle Tissue Myofibroma Neoplasms by Histologic Type Uterine Hemorrhage Uterine Diseases Leiomyoma Genital Diseases, Female |
Neoplasms, Connective and Soft Tissue Neoplasms Pathologic Processes Menstruation Disturbances Connective Tissue Diseases Menorrhagia Neoplasms, Connective Tissue |