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Injection Versus Suture Repair of Laryngeal Clefts
Sponsor: Oregon Health and Science University
Summary
The purpose of the study is to learn more about a procedure that may be helpful for the participant's swallowing issues. The investigators are hoping to find out if one type of procedure is the same or better than another type of procedure at improving participant's issues with swallowing. Participants will get one of two procedures. One is called injection laryngoplasty (IL) and injects a gel into the back wall of the participant's airway to prevent food and liquid from falling in. The other procedure is called endoscopic suture repair (ER) and uses sutures to sew together and build up the back wall of the participant's airway to prevent food and liquid from falling in. Participants will be asked to have a number of tests and procedures. These include a modified barium swallow study, in which the participant drinks and eats foods and liquids with barium in them and X-rays are used to assess how the food moves through the participant's body. This will be done before the procedure and 3 months after the procedure. The investigators will also give participants questionnaires to complete before and after the procedure.
Official title: Injection Versus Suture Repair of Laryngeal Clefts, A Randomized, Controlled Trial
Key Details
Gender
All
Age Range
12 Months - 10 Years
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2025-09-01
Completion Date
2026-12-30
Last Updated
2025-09-29
Healthy Volunteers
No
Conditions
Interventions
Endoscopic suture repair
Children receiving endoscopic suture repair of laryngeal cleft
Injection laryngoplasty
Children receiving injection of the interarytenoid space for laryngeal cleft treatment
Locations (2)
Oregon Health & Science University
Portland, Oregon, United States
Vanderbilt University
Nashville, Tennessee, United States