Status:
COMPLETED
Pilot Study Evaluating Characteristic Closure Patterns of the Normal Velopharyngeal Portal
Lead Sponsor:
University of Pittsburgh
Conditions:
Cleft Palate
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This prospective research study seeks to determine how the normal velopharyngeal mechanism compares, both anatomically and physiologically, with previous data obtained on subjects with submucous cleft...
Detailed Description
Televex videofluoroscopy utilizes real-time, x-ray imaging to visualize the velopharyngeal port from multiple views or planes. The views generally utilized include the lateral, base and frontal. This ...
Eligibility Criteria
Inclusion
- All subjects for this study are adults.
- In this study, the most significant risk is that of radiation exposure, which for Televex videofluoroscopy, is comparable to a single undergoing a single x-ray study, and is significantly less than most CT scans.
- There are no risks to a fetus or pregnant subject involved in this study, nor are there any interventions involved in the research that may be associated with reproductive risks, because all female participants will be given a urine pregnancy test prior to undergoing the Televex Videofluoroscopy.
- All participants will wear protective lead torso and pelvic shields, which are standard for all personnel in a room where a radiologic evaluation is being performed.
Exclusion
- The subjects for this study are all adult.
- None of the participants will be children because we are looking for subjects who have reached skeletal maturity which happens around the age of 18 years old
- Any positive urine pregnancy test results would exclude the female subject from this study.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00773994
Start Date
May 1 2008
End Date
July 15 2015
Last Update
October 18 2017
Active Locations (1)
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1
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213