Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-04 @ 6:34 PM
Study NCT ID:
NCT00773994
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2008-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study Evaluating Characteristic Closure Patterns of the Normal Velopharyngeal Portal
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Pilot Study Evaluating Characteristic Closure Patterns of the Normal Velopharyngeal Portal
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 technique requires the subject to provide specific speech patterns, as presented by a speech pathologist, while a radiologist obtains adequate views of the velopharyngeal (VP) port. Each procedure will take about 3 to 5 minutes. Fluoroscopic imaging is provided only during speech tasks and swallowing limiting radiation exposure.
1\) The radiologist begins by taking a lateral view while speaking, which allows viewing of the velum and posterior pharyngeal wall during speech production, as well as evaluation of cranial base angle, size and location of adenoid tissue, velar length, velar thickness and velar stretch. 2) The speech pathologist gives the subject barium sulfate contrast, approximately 2 to 4 oz, to swallow, which allows for better structure delineation, as well as the confirmation of the presence of palatal fistulae if barium passes through the palate during swallowing. 3) The speech pathologist places the subject in a supine position and barium sulfate is then instilled into the nasal passages bilaterally via syringe, approximately 5 ml. approximately 2. 5 ml in each nostril. This allows for nasopharyngeal coating of structures. 4) The speech pathologist then places the subject in the prone on the table and positioned into a sphinx position with head and neck extended and forearms and palms flat on the fluoroscopic table. The head, shoulders and neck are positioned to find the base view of the velopharyngeal port. This view affords the ability to obtain velopharyngeal closure patterns and size of velopharyngeal defect similar to that of nasopharyngoscopy. 5) The next view obtained by the radiologist is the frontal or anterior-posterior. This is obtained with the head/neck extended to allow for evaluation of the degree of lateral pharyngeal wall motion. 6) The final view obtained by the radiologist is a repeat of the initial lateral view this time with the nasopharyngeal coating in place. This can be beneficial in confirming VPI in the presence of a small VP gap. During the coated lateral view blowing of barium through the VP port can be observed. Additionally if barium is not dissipated during velopharyngeal closure this can be indicative of anatomic VPI. This is all done in the radiology department and takes approximately 3 minutes to 5 minutes.
1\) The radiologist begins by taking a lateral view while speaking, which allows viewing of the velum and posterior pharyngeal wall during speech production, as well as evaluation of cranial base angle, size and location of adenoid tissue, velar length, velar thickness and velar stretch. 2) The speech pathologist gives the subject barium sulfate contrast, approximately 2 to 4 oz, to swallow, which allows for better structure delineation, as well as the confirmation of the presence of palatal fistulae if barium passes through the palate during swallowing. 3) The speech pathologist places the subject in a supine position and barium sulfate is then instilled into the nasal passages bilaterally via syringe, approximately 5 ml. approximately 2. 5 ml in each nostril. This allows for nasopharyngeal coating of structures. 4) The speech pathologist then places the subject in the prone on the table and positioned into a sphinx position with head and neck extended and forearms and palms flat on the fluoroscopic table. The head, shoulders and neck are positioned to find the base view of the velopharyngeal port. This view affords the ability to obtain velopharyngeal closure patterns and size of velopharyngeal defect similar to that of nasopharyngoscopy. 5) The next view obtained by the radiologist is the frontal or anterior-posterior. This is obtained with the head/neck extended to allow for evaluation of the degree of lateral pharyngeal wall motion. 6) The final view obtained by the radiologist is a repeat of the initial lateral view this time with the nasopharyngeal coating in place. This can be beneficial in confirming VPI in the presence of a small VP gap. During the coated lateral view blowing of barium through the VP port can be observed. Additionally if barium is not dissipated during velopharyngeal closure this can be indicative of anatomic VPI. This is all done in the radiology department and takes approximately 3 minutes to 5 minutes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: