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Laryngeal CleftChildren's healthProcedure

What this study is

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.

What's being tested

  • Endoscopic suture repair

    Intervention · PROCEDURE

    Children receiving endoscopic suture repair of laryngeal cleft

  • Injection laryngoplasty

    Intervention · PROCEDURE

    Children receiving injection of the interarytenoid space for laryngeal cleft treatment

Study details

Official title
Injection Versus Suture Repair of Laryngeal Clefts, A Randomized, Controlled Trial
Sponsor
Oregon Health and Science University
Conditions
Laryngeal Cleft · Dysphagia
Enrolling
128 people
Starts
2025-09-01
Est. completion
2026-12-30
Design
Triple-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗