Cardiovascular AbnormalitiesNCT00229853
Thoracoscopic Vascular Rings Chart Review
An observational study of Cardiovascular Abnormalities, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The purpose of this study is to review the use of diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Abnormalities
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jul 2007
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: retro chart review
Who may be able to join
- All patients undergoing vascular ring division at Children's Healthcare of Atlanta at Egleston Hospital between 2001 and 2004
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
About this study
The purpose of this study is to review the use of diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome.
Read the detailed description
In addition to dividing the vascular ring, some surgeons stress the importance of performing a diverticulopexy (an additional stitch which holds the ring open and prevents recurrence). This is a difficult step to perform through the thoracoscope.
We plan to review the use of this step, the diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome. Once we have accomplished this, we hope to present our initial results of this new procedure.
- Conditions
- Cardiovascular Abnormalities
- Keywords
- Children's Healthcare of Atlanta, pediatric, Thoracoscopic Vascular ring, diverticulopexy, Vascular Ring Division
- Medical subject headings
- Cardiovascular Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startAug 2004
- Study completionJul 2007
Why it stopped: sufficient data gathered to support hypothesis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular AbnormalitiesStudies 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
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Brian Kogon, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229853
- Sponsor's protocol ID
- 04-069
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2005
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Vascular Rings Chart Review
- ClinicalTrials.gov ID
- NCT00229853
- Acronym / sponsor ID
- 04-069
- Conditions
- Cardiovascular Abnormalities
- Keywords
- Children's Healthcare of Atlanta, pediatric, Thoracoscopic Vascular ring, diverticulopexy, Vascular Ring Division
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: sufficient data gathered to support hypothesis
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 30 Sep 2005 (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.
The purpose of this study is to review the use of diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome.
Detailed description
In addition to dividing the vascular ring, some surgeons stress the importance of performing a diverticulopexy (an additional stitch which holds the ring open and prevents recurrence). This is a difficult step to perform through the thoracoscope.
We plan to review the use of this step, the diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome. Once we have accomplished this, we hope to present our initial results of this new procedure.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- retro chart review
Key inclusion criteria (1 listed)
- All patients undergoing vascular ring division at Children's Healthcare of Atlanta at Egleston Hospital between 2001 and 2004
Key exclusion criteria (0 listed)
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: sufficient data gathered to support hypothesis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
Related trials for Cardiovascular Abnormalities
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingObservational study
Coronary Myocardial Bridge and Coronary Plaques on MDCT
Myocardial Bridging, Coronary Atherosclerosis
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
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.
Brian Kogon, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Abnormalities, run by Children's Healthcare of Atlanta at 1 site 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 0 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 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: sufficient data gathered to support hypothesis). 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 6 Jul 2011.