Injection Versus Suture Repair of Laryngeal Clefts

NCT ID: NCT07057258

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-12-30

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.

Detailed Description

This study has 2 study groups.

• Group 1 will get IL for this condition.
• Group 2 will get ER for this condition

A computer will assign each participant to a group in no particular order. This is called randomization. Half of participants in this study will get IL. Half of participants will get ER. Each participant will have an equal chance of being in either group.

Neither the participants, the study doctor(s), nor the speech pathologist will know whether each participant will get the IL or ER. Only the surgeon will know which treatment the participant gets. The study is done this way because knowing which method the participant receives can change the results of the study.

If participants experience any serious side effects, the study doctor can find out which method they received so that any side effects can be treated properly.

Participants will need to have the following tests to find out if they can be in the study:

• Physical exam
• Demographic information/medical history
• Video fluoroscopic swallow study (VFSS) - X-ray videos that allow investigators to watch how food and liquids go down as a participant swallows them

If participant's screening tests show that they can take part in the study and they choose to be part of the study, they will also have to do the following tests:

• VFSS 3 months after the procedure
• Questionnaires asking about the emotional and physical burden of participant's swallowing issues, both before and after the procedure
• Overnight monitoring in the hospital after the procedure
• Follow up in clinic for up to 2 years after the procedure

Participant's medical records may be reviewed. Information reviewed may include treatment history, medications, surgeries, allergies, scans, and lab results.

Once participant's participation in the study ends, their medical provider(s) will help them choose the next step in their care.

Conditions

Laryngeal Cleft; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Endoscopic suture repair

Children receiving endoscopic suture repair of laryngeal cleft

Group Type: EXPERIMENTAL

Endoscopic suture repair

Intervention Type: PROCEDURE

Children receiving endoscopic suture repair of laryngeal cleft

Injection laryngoplasty

Children receiving injection of the interarytenoid space of laryngeal cleft

Group Type: ACTIVE_COMPARATOR

Injection laryngoplasty

Intervention Type: PROCEDURE

Children receiving injection of the interarytenoid space for laryngeal cleft treatment

Interventions

Endoscopic suture repair

Children receiving endoscopic suture repair of laryngeal cleft

Intervention Type: PROCEDURE

Injection laryngoplasty

Children receiving injection of the interarytenoid space for laryngeal cleft treatment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Derek Lam, MD, MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University

Portland, Oregon, United States

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

STUDY00027965

Identifier Type: -

Identifier Source: org_study_id