Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01198652
Recruitment Status : Terminated (Study discontinued following 57 subjects enrolled over 2 years)
First Posted : September 10, 2010
Last Update Posted : March 5, 2013
Information provided by (Responsible Party):
Glenveigh Medical

Brief Summary:
This is an open, post-marketing surveillance study obtaining data retrospectively on 300 women, of any age, treated with the BD-OTS for postpartum uterine bleeding.

Condition or disease
Postpartum Uterine Bleeding

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program
Study Start Date : September 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Bleeding
U.S. FDA Resources

Belfort-Dildy Obstetric Tamponade Tx
Patients treated with Belfort-Dildy Obstetric Tamponade System are eligible for inclusion in the cohort.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have received treatment with the BD-OTS as part of their standard of care in hospital.

Inclusion Criteria:

  • Treatment with the BD-OTS device

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01198652

United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, Colorado
Presbyterian/St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Florida
Orlando Health
Orlando, Florida, United States, 32806
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07440
United States, New York
UHS - Wilson Medical Center
Johnson City, New York, United States, 13790
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0457
Toledo Hospital
Toledo, Ohio, United States, 43606
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Chattanooga, Tennessee, United States, 37403
United States, Texas
St. David's Medical Center
Austin, Texas, United States, 78705
North Austin Medical Center - St. David's Women's Center of Texas
Austin, Texas, United States, 78758
Sponsors and Collaborators
Glenveigh Medical
Study Director: David Adair, MD Glenveigh Medical

Responsible Party: Glenveigh Medical Identifier: NCT01198652     History of Changes
Other Study ID Numbers: 04
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Pathologic Processes