Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program

This study has been terminated.
(Study discontinued following 57 subjects enrolled over 2 years)
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014