Evaluation of a Novel Nasal Conformer in Pediatric Patients

NCT ID: NCT06885801

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2030-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cleft Lip Nasal Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type OTHER

use of an anatomically designed nasal conformer

Intervention Type 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

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

Group Type OTHER

use of an anatomically designed nasal conformer

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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East Tennessee Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Justin Daggett

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Justin Daggett, MD

Role: CONTACT

18658244939

Other Identifiers

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IRB-2025-069

Identifier Type: -

Identifier Source: org_study_id

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