Evaluation of a Novel Nasal Conformer in Pediatric Patients

Conditions

• Cleft Lip
• Nasal Surgical Procedures

Eligibility Criteria

Sex

ALL

Age

N/A - 18 Years

Healthy Volunteers

Not accepted

Interventions

• use of an anatomically designed nasal conformer — DEVICE
  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

Study Details

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.

Key Dates

First listed

Mar 20, 2025

Start date

Jun 1, 2025

Status verified

Sep 2026

Primary completion

Jun 1, 2030

Completion

Dec 1, 2030

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DEVICE_FEASIBILITY

Arms

• Other: Standard first, anatomic second
  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
• Other: Anatomic first, standard second
  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

Primary Outcome Measure

Ease of use [ Time Frame: 6 months ]

Locations (1)

Find similar trials in Knoxville, TN

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