NCT00866827

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2014

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

11.4 years

First QC Date

December 17, 2007

Last Update Submit

January 10, 2019

Conditions

HemangiomasVenous MalformationsLymphatic Malformations

Keywords

AirwayHemangiomasVenous MalformationsLymphatic Malformations

Interventions

Protocols for TreatmentOTHER

Determine protocols for treatment of airway vascular malformation and to evaluate results from treatment of these lesions.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in the ACH database that have been treated in the last ten years for airway vascular lesions.

You may qualify if:

  • Airway Vascular Lesion

You may not qualify if:

  • None at this time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HemangiomaLymphatic Abnormalities

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasmsLymphatic DiseasesHemic and Lymphatic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Gresham T Richter, M.D.

    UAMS, ACH, Central Arkansas Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

  • Jessica L Boswell, BS, CRS

    UAMS, ACH, Central Arkansas Veterans Healthcare System

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2007

First Posted

March 23, 2009

Study Start

December 1, 2002

Primary Completion

April 15, 2014

Study Completion

April 15, 2014

Last Updated

January 11, 2019

Record last verified: 2019-01