Pilot Study Evaluating Characteristic Closure Patterns of the Normal Velopharyngeal Portal

Completed · Not applicable

Conditions studied: Cleft Palate

In brief

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 palate (SMCP) in IRB#07080395.

Key facts

Study ID

NCT00773994

Run by

University of Pittsburgh

People needed

4

Starts

2008-05-01

Expected to finish

2015-07-15

Last updated by the study team

2017-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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