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 ↗
Who can join
Age 12 Months – 10 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Children aged 12 months - 10 years referred to a multi-disciplinary aerodigestive clinic with evidence of penetration or aspiration on VFSS, requiring any amount of thickening of liquids and unable to wean after 2-month trial of thickened liquids.
You can't join if
- Cerebral palsy
- Down syndrome
- Prematurity < 28 weeks gestational age
- Hypoxic brain injury
- Any syndrome with significant hypotonia
- History of nothing by mouth (NPO) for > 1 month prior to assessment
- >50% of nutrition by G-tube
- Tracheostomy
- History of prior IL or ER
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (2)
2 openOregon Health & Science University
Portland, Oregon, United States
Vanderbilt University
Nashville, Tennessee, United States
Study team
Sponsor
Oregon Health and Science University
Study ID STUDY00027965
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.