A Phase 2 interventional study of use of an anatomically designed nasal conformer in Cleft Lip and Nasal Surgical Procedures, sponsored by East Tennessee Children's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by East Tennessee Children's Hospital · Phase 2, Interventional, and Device feasibility
This study compares the current commercially available nasal conformer available for use in cleft lip repair and nasal scar release to a novel, anatomically shaped conformer based upon typical nasal airspace shape. This will follow patients using both of these types of splints during the post-operative healing process with one group starting with the standard splint and then moving to the anatomic conformer and the second group beginning with the anatomic and them moving to the standard conformer. This study will evaluate the patient experience and outcomes of the 2 types of conformers, looking at the discomfort, device dislodgements, ease of use and occurrence of complications such as skin irritation and rashes or skin breakdown.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →This is the only study on the registry with East Tennessee Children's Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients are started with the standard nasal conformer for the first 3 months and then switched to the anatomic conformer for the second 3 months
Device: use of an anatomically designed nasal conformer
Patients are started with the anatomic nasal conformer for the first 3 months and then switched to the standard conformer for the second 3 months
Device: use of an anatomically designed nasal conformer
this study will evaluate the use of a nasal conformer that has been designed to match the internal airway anatomy of the anterior nose rather than the standard hollow, conical conformer currently available on the market
Ease of use
The patients or (parents for younger patients) will complete a questionnaire at the end of 3 months and 6 months after using each of the various types of conformer. These questionnaires will consist of a grading scale evaluating each of the conformer is a based on the ease of cleaning, inserting, and keeping the stent in place is evaluated
Time frame: 6 months
safety of the conformer
The patients or (parents of younger patients) will complete a questionnaire at the end of 3 months and 6 months after using each of the various types of conformer. The these will give them the opportunity to report the occurrence of adverse events such as skin rashes, skin irritation, skin breakdown, or stent breakage.
Time frame: 6 months
Started Jun 2025 (actual). Primary completion is estimated for Jun 2030, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.