- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00577213
Diagnosis of Hemangiomas and Vascular Malformations
October 25, 2012 updated by: University of Arkansas
Diagnosis of Hemangiomas and Vascular Malformations Using Non-invasive Imaging Devices
To develop a non-invasive, simple and affordable, measurement technique to differentiate hemangiomas from subtypes of VMS.
The purpose of this study is to determine the best office based diagnositc instrument for differentiating the subtype of vascular lesions.
The instrument must be simple and affordable so it can be used by primary car physicians in the doctor office.
The procedure will be based on non-invasive and unharmful measurements that will be compared to the diagnosis from specialized physicians in this field and the final pathology.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
56
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
No older than 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects with vascular lesions from the patient populations at Arkansas Children's Hospital (ACH) and the University of Arkansas for Medical Sciences (UAMS) will be recruited for the study.
Approximately 45 subjects from Arkansas Children's Hospital and approximately 10 subjects from the University of Arkansas for Medical Sciences will be recruited for a total of 55.
Description
Inclusion Criteria:
- Suspected Hemangioma, Vascular Malformations (VMS) including venular Malformations (port-wine stain, PWS), Venous Malformations, Lymphatic Malformations, Arteriovenous Malformations or mixed malformations.
Exclusion Criteria:
- All pregnant individuals will be excluded, since physiologic changes of pregnancy could alter characteristics of the vascular lesion.
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: Cohort
- Time Perspectives: Cross-Sectional
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gal Shafirstein, Ph.D., UAMS, ACH, Central Arkansas Veterans Healthcare System
- Study Director: Jessica L Boswell, UAMS, ACH, Central Arkansas Veterans Healthcare System
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
February 1, 2007
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
December 18, 2007
First Submitted That Met QC Criteria
December 18, 2007
First Posted (Estimate)
December 20, 2007
Study Record Updates
Last Update Posted (Estimate)
October 26, 2012
Last Update Submitted That Met QC Criteria
October 25, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Cardiovascular Abnormalities
- Neoplasms, Vascular Tissue
- Lymphatic Vessel Tumors
- Congenital Abnormalities
- Hemangioma
- Arteriovenous Malformations
- Vascular Malformations
- Lymphangioma
- Lymphatic Abnormalities
Other Study ID Numbers
- 47573
- Chancellor's Fund
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 Arteriovenous Malformations
-
Centre hospitalier de l'Université de Montréal...Active, not recruitingUnruptured Brain Arteriovenous Malformation | Ruptured Brain Arteriovenous Malformation | Arteriovenous Malformations, CerebralCanada, France
-
University of ArkansasGenentech, Inc.RecruitingArteriovenous Malformations (Extracranial)United States
-
Fondation Ophtalmologique Adolphe de RothschildRecruitingCerebral Arteriovenous Malformations | Ruptured or Unruptured Cerebral Arteriovenous MalformationsFrance
-
Embo-Flüssigkeiten A.G.Active, not recruitingCerebral Arteriovenous MalformationFrance, Denmark, Germany, Belgium, Italy
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruiting
-
Medtronic Neurovascular Clinical AffairsCompletedCerebral Arteriovenous MalformationsFrance
-
Microvention-Terumo, Inc.ClinSearchTerminatedCerebral AV MalformationUnited Kingdom, Spain, Denmark, France, Sweden
-
yuanli ZhaoPeking University International HospitalRecruitingCerebral Arteriovenous MalformationChina
-
Dr. Markus Alfred MöhlenbruchUniversity Hospital Schleswig-HolsteinCompletedDural Arteriovenous FistulaGermany
-
Beijing Tiantan HospitalNot yet recruitingCerebral Arteriovenous MalformationChina