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Custom-Shaped nose splint may ease recovery for kids after cleft lip surgery

NCT ID NCT06885801

Symptom relief Sponsor: East Tennessee Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Children who have cleft lip repair or nasal scar release often wear a nasal splint while healing. This trial compares the standard hollow, cone-shaped conformer with a new one shaped to match the inside of the nose. Each child tries both types, switching halfway through, and parents or patients answer questionnaires about comfort, cleaning, how well the splint stays in, and any skin problems. Researchers want to see which conformer is easier to use and causes fewer issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an anatomically designed nasal conformer
What this could lead to
If the anatomic conformer works better, it could become a more comfortable and easier-to-use option for children healing after cleft lip repair or nasal scar release.
What could go wrong
This is a small Phase 2 study with only 20 children, so the results may not apply to everyone. The new conformer could cause more skin irritation or dislodge more often than the standard one.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient's undergoing primary cleft lip repair or release of nasal scarring Exclusion Criteria: * patient or parents declined participation postoperative nasal stenting is judged clinically inappropriate

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Conditions

The condition(s) this trial relates to.

cleft lip

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cleft lip Nasal surgical procedures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37916, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.