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ENROLLING BY INVITATION
NCT07057258
NA

Injection Versus Suture Repair of Laryngeal Clefts

Sponsor: Oregon Health and Science University

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Endoscopic suture repair

Children receiving endoscopic suture repair of laryngeal cleft

PROCEDURE

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