Evaluation of a Novel Nasal Conformer in Pediatric Patients

NCT06885801 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: IRB-2025-069
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cleft Lip; Nasal Surgical Procedures

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  6 months

Study Arms (2)

Standard first, anatomic second

OTHER

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

Anatomic first, standard second

OTHER

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

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

Anatomic first, standard second; Standard first, anatomic second

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient's undergoing primary cleft lip repair or release of nasal scarring

You may not qualify if:

• patient or parents declined participation postoperative nasal stenting is judged clinically inappropriate

Sponsors & Collaborators

• East Tennessee Children's Hospital: lead

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Justin Daggett, MD

CONTACT

18658244939; jrdaggett@etch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 20, 2025

Record last verified: 2025-03