Injection Versus Suture Repair of Laryngeal Clefts

NCT07057258 | Enrolling By Invitation DMC

• 1 other identifier: STUDY00027965
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Laryngeal Cleft; Dysphagia

Keywords

endoscopic suture repair; injection laryngoplasty; pediatrics; otolaryngology; dysphagia; laryngeal cleft

Outcome Measures

Primary Outcomes (1)

• Resolution of penetration/aspiration

  No thickener needed on speech pathologist assessment of video fluoroscopic swallow study

  3 months post operative

Secondary Outcomes (5)

• Compare change in recommended liquid thickness

  at enrollment and 3 months post intervention

• change in penetration/aspiration score

  at enrollment and 3 months post intervention

• change in feeding and swallowing impact survey (FSIS) scores

  at enrollment and 3 months post intervention

• change in quality of life scores

  at enrollment and 3 months post intervention

• Change in laryngeal cleft quality of life (LC-QOL) scores

  at enrollment and 3 months post intervention

Study Arms (2)

Endoscopic suture repair

EXPERIMENTAL

Children receiving endoscopic suture repair of laryngeal cleft

Procedure: Endoscopic suture repair

Injection laryngoplasty

ACTIVE COMPARATOR

Children receiving injection of the interarytenoid space of laryngeal cleft

Procedure: Injection laryngoplasty

Interventions

Endoscopic suture repair PROCEDURE

Children receiving endoscopic suture repair of laryngeal cleft

Endoscopic suture repair

Injection laryngoplasty PROCEDURE

Children receiving injection of the interarytenoid space for laryngeal cleft treatment

Injection laryngoplasty

Eligibility Criteria

• Age: 12 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You 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 may not qualify 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Laryngeal cleft; Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)