Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program

March 4, 2013 updated by: Glenveigh Medical
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

Inclusion Criteria:

  • Treatment with the BD-OTS device

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glenveigh Medical

Investigators

  • Study Director: David Adair, MD, Glenveigh Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postpartum Uterine Bleeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe