Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program
This study has been terminated.
(Study discontinued following 57 subjects enrolled over 2 years)
Sponsor:
Glenveigh Medical
Information provided by (Responsible Party):
Glenveigh Medical
ClinicalTrials.gov Identifier:
NCT01198652
First received: September 9, 2010
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
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 |
|---|
|
Postpartum Uterine Bleeding |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program |
Resource links provided by NLM:
Further study details as provided by Glenveigh Medical:
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Belfort-Dildy Obstetric Tamponade Tx
Patients treated with Belfort-Dildy Obstetric Tamponade System are eligible for inclusion in the cohort.
|
Eligibility| Genders 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.
Criteria
Inclusion Criteria:
- Treatment with the BD-OTS device
Exclusion Criteria:
- None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198652
Locations
| 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 | |
| Erlanger | |
| 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
Investigators
| Study Director: | David Adair, MD | Glenveigh Medical |
More Information
No publications provided
| Responsible Party: | Glenveigh Medical |
| ClinicalTrials.gov Identifier: | NCT01198652 History of Changes |
| Other Study ID Numbers: | 04 |
| Study First Received: | September 9, 2010 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hemorrhage Uterine Hemorrhage Pathologic Processes Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 18, 2013