Laryngeal CleftNCT07057258
Injection Versus Suture Repair of Laryngeal Clefts
A study testing Endoscopic suture repair and Injection laryngoplasty in people with Laryngeal Cleft and Dysphagia, run by Oregon Health and Science University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 10 years
- Conditions the study is for
- Laryngeal Cleft, Dysphagia
- What is being tested?
- Endoscopic suture repair and Injection laryngoplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- >50% of nutrition by G-tube
- Tracheostomy
- History of prior IL or ER
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Vanderbilt University
Nashville, Tennessee, 37232
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Injection Versus Suture Repair of Laryngeal Clefts, A Randomized, Controlled Trial
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.
Read the 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
- Being tested
- Endoscopic suture repair, Injection laryngoplasty
- Keywords
- endoscopic suture repair, injection laryngoplasty, pediatrics, otolaryngology, dysphagia, laryngeal cleft
- Medical subject headings
- Laryngeal cleft, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic suture repairProcedure or surgery
Children receiving endoscopic suture repair of laryngeal cleft
Injection laryngoplastyProcedure or surgery
Children receiving injection of the interarytenoid space for laryngeal cleft treatment
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic suture repair | Experimental | Children receiving endoscopic suture repair of laryngeal cleft Receives: Procedure: Endoscopic suture repair |
| Injection laryngoplasty | Active comparator | Children receiving injection of the interarytenoid space of laryngeal cleft Receives: Procedure: Injection laryngoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of penetration/aspiration
No thickener needed on speech pathologist assessment of video fluoroscopic swallow study
Measured: 3 months post operative
Secondary outcomes (5)
Compare change in recommended liquid thickness
The recommend liquid thickness according to speech pathologist assessment of video fluoroscopic swallow study review will be converted to a numerical scale and compared to pre-intervention recommended thickness to determine the degree of change after the intervention. The liquid thickness will be measured based on the IDDSI (International Dysphagia Diet Standardisation Initiative) Framework in which recommended liquid is scored as thin (0), slightly thick (1), mildly thick (2), moderately thick (3), or extremely thick (4). Higher scores indicate need for thicker liquids and therefore higher degree of dysphagia.
Measured: at enrollment and 3 months post intervention
change in penetration/aspiration score
The score according to the Penetration-Aspiration scale rating of the video fluoroscopic swallow study data will be compared before and after the intervention. The Penetration-Aspiration scale includes: material does not enter the airway (1), material enters the airway, remains above the vocal folds, and is ejected from the airway (2), material enters the airway, remains above the vocal folds, and is not ejected from the airway (3), material enters the airway, contacts the vocal folds, and is ejected from the airway (4), material enters the airway, contacts the vocal folds, and is not ejected from the airway (5), material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway (6), material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort (7), material enters the airway, passes below the vocal folds, and no effort is made to eject (8). Higher scores indicate higher degree of dysphagia.
Measured: at enrollment and 3 months post intervention
change in feeding and swallowing impact survey (FSIS) scores
Survey data including FSIS will be analyzed and change in score will be calculated before and after the intervention. The FSIS is a validated survey that includes 18 statements that caregivers rate on a scale of 1 to 5 in which lower scores indicate better quality of life.
Measured: at enrollment and 3 months post intervention
change in quality of life scores
Survey data including the Child Health Questionnaire (CHQ) for children aged five years and older or the Infant Toddler Quality of Life Questionnaire (ITQOL) for children aged under five years will be analyzed and change in score will be calculated before and after the intervention. The CHQ consists of 28 questions that assess the global quality of life of the child. The ITQOL consists of 47 questions that assess the global quality of life of the child. Based on the responses, the questionnaires are converted to a scale that ranges from 0 (worst possible score) to 100 (best possible score).
Measured: at enrollment and 3 months post intervention
Change in laryngeal cleft quality of life (LC-QOL) scores
Survey data including LC-QOL will be analyzed and change in score will be calculated before and after the intervention. The LC-QOL is a 40 item questionnaire designed to assess quality of life in caregivers of patients with laryngeal cleft. Each item is scored from 0 to 5 in which lower scores indicate more significant negative impact on quality of life due to caring for a child with laryngeal cleft.
Measured: at enrollment and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal CleftStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Lam, MD, MPH, American Academy of Otolaryngology-Head and Neck Surgery Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057258
- Sponsor's protocol ID
- STUDY00027965
- Status last verified
- Sep 2025
- First submitted
- 2 Jun 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Versus Suture Repair of Laryngeal Clefts, A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07057258
- Acronym / sponsor ID
- STUDY00027965
- Conditions
- Laryngeal Cleft, Dysphagia
- Keywords
- endoscopic suture repair, injection laryngoplasty, pediatrics, otolaryngology, dysphagia, laryngeal cleft
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Endoscopic suture repair | Experimental | Procedure: Endoscopic suture repairChildren receiving endoscopic suture repair of laryngeal cleft |
| Injection laryngoplasty | Active comparator | Procedure: Injection laryngoplastyChildren receiving injection of the interarytenoid space of laryngeal cleft |
Who may qualify
- Ages
- 12 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- Cerebral palsy
- Down syndrome
- Prematurity < 28 weeks gestational age
- Hypoxic brain injury
- Any syndrome with significant hypotonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic suture repairChildren receiving endoscopic suture repair of laryngeal cleft | Procedure or surgery | Endoscopic suture repair |
| Injection laryngoplastyChildren receiving injection of the interarytenoid space for laryngeal cleft treatment | Procedure or surgery | Injection laryngoplasty |
Primary outcome
Resolution of penetration/aspiration
Time frame: 3 months post operative
No thickener needed on speech pathologist assessment of video fluoroscopic swallow study
5 secondary outcomes
Compare change in recommended liquid thickness
Time frame: at enrollment and 3 months post intervention
change in penetration/aspiration score
Time frame: at enrollment and 3 months post intervention
change in feeding and swallowing impact survey (FSIS) scores
Time frame: at enrollment and 3 months post intervention
change in quality of life scores
Time frame: at enrollment and 3 months post intervention
Change in laryngeal cleft quality of life (LC-QOL) scores
Time frame: at enrollment and 3 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic suture repair and Injection laryngoplasty in people with Laryngeal Cleft and Dysphagia, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of penetration/aspiration (time frame: 3 months post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.