Injection Versus Suture Repair of Laryngeal Clefts

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT07057258
Status
Enrolling By Invitation

Conditions

  • Dysphagia
  • Laryngeal Cleft

Eligibility Criteria

Sex
ALL
Age
12 Months - 10 Years
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic suture repair — PROCEDURE
    Children receiving endoscopic suture repair of laryngeal cleft
  • Injection laryngoplasty — PROCEDURE
    Children receiving injection of the interarytenoid space for laryngeal cleft treatment

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
Sep 2025
Primary completion
Sep 1, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Endoscopic suture repair
    Children receiving endoscopic suture repair of laryngeal cleft
  • Active Comparator: Injection laryngoplasty
    Children receiving injection of the interarytenoid space of laryngeal cleft

Primary Outcome Measure

Resolution of penetration/aspiration [ Time Frame: 3 months post operative ]

Locations (2)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239-
Vanderbilt UniversityNashvilleTennessee37232-

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Oregon Health & Science University· Portland, ORVanderbilt University· Nashville, TN

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