Pilot Study Evaluating Characteristic Closure Patterns of the Normal Velopharyngeal Portal

NCT00773994 | Completed

• 1 other identifier: 07100381
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 palate (SMCP) in IRB#07080395.

Conditions

Cleft Palate

Keywords

anterior palatal eminence; palatal elevation above the maxillary plane; anterior uvular prolapse; "inverted-V" present in base view.

Outcome Measures

Primary Outcomes (1)

• Normalnormal velopharyngeal mechanism vs abnormal

  2 years or 10 subjects.

Study Arms (1)

Normal velopharyngeal mechanism

OTHER

All participants in this study are normal healthy adults, who have agreed to undergo to a videofluoroscopic Televex. These participants are acceptable control subjects because they are not diagnosed with VPI and/or submucous cleft palate (SMCP) and the velopharyageal mechanism functions the same in adults as it does in children. This procedure will take approximately 3 minutes to 5 minutes.

Other: Normal Velopharyngeal Mechansim

Interventions

Normal Velopharyngeal Mechansim OTHER

The amount of radiation exposure that you will receive from this procedure is about 0.3 rem to the head and neck, with minimal exposure of the other body areas.

Normal velopharyngeal mechanism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jennifer Szczepaniak, BS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ross H. Musgrave Professor of Pediatric Plastic Surgery Executive Vice-Chair and Program Director Department of Plastic Surgery University of Pittsburgh Medical Center

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2015
• Study Completion: July 15, 2015
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

US (1)