NCT06885801

Evaluation of a Novel Nasal Conformer in Pediatric Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: East Tennessee Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-01
• Primary completion: 2030-06-01
• Completion: 2030-12-01
• First posted: 2025-03-20
• Last updated: 2025-03-20

Regulatory

• FDA-regulated device study