HemangiomasNCT00866827
Airway Vascular Lesions
An observational study of Hemangiomas and Venous Malformations, run by University of Arkansas.
Trial summary
Controversy exists in the treatment of airway hemangiomas ranging from tracheotomy, various lasers, to open removal, none of which have proven to be a gold standard. Venous malformations of the airway are difficult to treat and also require laser therapy or open removal and often repeated treatments are required. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemangiomas, Venous Malformations, Lymphatic Malformations
- What is being tested?
- Protocols for Treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to 15 Apr 2014
- 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: All patients in the ACH database that have been treated in the last ten years for airway vascular lesions.
Who may be able to join
- Airway Vascular Lesion
Who cannot join
- None at this time
About this study
Controversy exists in the treatment of airway hemangiomas ranging from tracheotomy, various lasers, to open removal, none of which have proven to be a gold standard. Venous malformations of the airway are difficult to treat and also require laser therapy or open removal and often repeated treatments are required. Similarly airway lymphatic malformations can require multiple treatment modalities as well as multiple procedures and are infrequently eradicated when extensive. New uses for various lasers and differing treatment protocols are frequently developed. Review of the treatment modalities and efficacy of these methods is required. The goal of this research is to determine protocols for treatment of airway vascular malformation and to evaluate our results from treatment of these lesions.
- Conditions
- Hemangiomas, Venous Malformations, Lymphatic Malformations
- Being tested
- Protocols for Treatment
- Keywords
- Airway, Hemangiomas, Venous Malformations, Lymphatic Malformations
- Medical subject headings
- Hemangioma, Lymphatic Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocols for TreatmentOther
Determine protocols for treatment of airway vascular malformation and to evaluate results from treatment of these lesions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startDec 2002
- Primary completion15 Apr 2014
- Study completion15 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemangiomasStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gresham T Richter, M.D., Principal investigator, UAMS, ACH, Central Arkansas Veterans Healthcare SystemJessica L Boswell, BS, CRS, Study director, UAMS, ACH, Central Arkansas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866827
- Sponsor's protocol ID
- 20969
- Other IDs
- Unfunded, Retrospective review
- Status last verified
- Jan 2019
- First submitted
- 17 Dec 2007
- Last updated
- 11 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Vascular Lesions
- ClinicalTrials.gov ID
- NCT00866827
- Acronym / sponsor ID
- 20969
- Conditions
- Hemangiomas, Venous Malformations, Lymphatic Malformations
- Keywords
- Airway, Hemangiomas, Venous Malformations, Lymphatic Malformations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- 15 Apr 2014 (actual)
- Study completion
- 15 Apr 2014 (actual)
- First posted
- 23 Mar 2009 (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.
Controversy exists in the treatment of airway hemangiomas ranging from tracheotomy, various lasers, to open removal, none of which have proven to be a gold standard. Venous malformations of the airway are difficult to treat and also require laser therapy or open removal and often repeated treatments are required. Similarly airway lymphatic malformations can require multiple treatment modalities as well as multiple procedures and are infrequently eradicated when extensive. New uses for various lasers and differing treatment protocols are frequently developed. Review of the treatment modalities and efficacy of these methods is required. The goal of this research is to determine protocols for treatment of airway vascular malformation and to evaluate our results from treatment of these lesions.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in the ACH database that have been treated in the last ten years for airway vascular lesions.
Key inclusion criteria (1 listed)
- Airway Vascular Lesion
Key exclusion criteria (1 listed)
- None at this time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocols for TreatmentDetermine protocols for treatment of airway vascular malformation and to evaluate results from treatment of these lesions. | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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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.
Gresham T Richter, M.D. principal investigator
UAMS, ACH, Central Arkansas Veterans Healthcare System
Jessica L Boswell, BS, CRS study director
UAMS, ACH, Central Arkansas Veterans Healthcare System
Questions about this trial
What is this clinical trial studying?
An observational study of Hemangiomas and Venous Malformations, run by University of Arkansas.
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: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 11 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.