Postpartum Uterine Bleeding Clinical Trial
Official title:
Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program
| Verified date | March 2013 |
| Source | Glenveigh Medical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 300 |
| Est. completion date | October 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Treatment with the BD-OTS device Exclusion Criteria: |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| United States | North Austin Medical Center - St. David's Women's Center of Texas | Austin | Texas |
| United States | St. David's Medical Center | Austin | Texas |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Erlanger | Chattanooga | Tennessee |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | Presbyterian/St. Luke's Medical Center | Denver | Colorado |
| United States | UHS - Wilson Medical Center | Johnson City | New York |
| United States | Monmouth Medical Center | Long Branch | New Jersey |
| United States | Orlando Health | Orlando | Florida |
| United States | Banner Good Samaritan Medical Center | Phoenix | Arizona |
| United States | Toledo Hospital | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Glenveigh Medical |
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