Postpartum Uterine BleedingNCT01198652
Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program
An observational study of Postpartum Uterine Bleeding, run by Glenveigh Medical at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Uterine Bleeding
- How many people
- 300 participants
- Where
- 11 sitesUnited States
- Study dates
- Sep 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have received treatment with the BD-OTS as part of their standard of care in hospital.
Who may be able to join
- Treatment with the BD-OTS device
Who cannot join
- None
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
St. David's Medical Center
Austin, Texas, 78705
North Austin Medical Center - St. David's Women's Center of Texas
Austin, Texas, 78758
Medical University of South Carolina
Charleston, South Carolina, 29425
Erlanger
Chattanooga, Tennessee, 37403
University of Cincinnati
Cincinnati, Ohio, 45267-0457
Presbyterian/St. Luke's Medical Center
Denver, Colorado, 80218
UHS - Wilson Medical Center
Johnson City, New York, 13790
Monmouth Medical Center
Long Branch, New Jersey, 07440
Orlando Health
Orlando, Florida, 32806
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
Toledo Hospital
Toledo, Ohio, 43606
About this study
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.
- Conditions
- Postpartum Uterine Bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Belfort-Dildy Obstetric Tamponade Tx | Patients treated with Belfort-Dildy Obstetric Tamponade System are eligible for inclusion in the cohort. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Study discontinued following 57 subjects enrolled over 2 years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glenveigh Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Adair, MD, Study director, Glenveigh Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198652
- Sponsor's protocol ID
- 04
- Status last verified
- Mar 2013
- First submitted
- 9 Sep 2010
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program
- ClinicalTrials.gov ID
- NCT01198652
- Acronym / sponsor ID
- 04
- Conditions
- Postpartum Uterine Bleeding
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study discontinued following 57 subjects enrolled over 2 years
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Glenveigh MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belfort-Dildy Obstetric Tamponade Tx | – | –Patients treated with Belfort-Dildy Obstetric Tamponade System are eligible for inclusion in the cohort. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have received treatment with the BD-OTS as part of their standard of care in hospital.
Key inclusion criteria (1 listed)
- Treatment with the BD-OTS device
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Study discontinued following 57 subjects enrolled over 2 years). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Adair, MD study director
Glenveigh Medical
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Uterine Bleeding, run by Glenveigh Medical at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study discontinued following 57 subjects enrolled over 2 years). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013.