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Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?

NCT05287841 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-09-20

No results posted yet for this study

Summary

The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of subjective and objective assessments.

Conditions

  • Nasal Obstruction
  • Septal Defect
  • Allergic Rhinitis
  • Nasal Polyps
  • Nasal Valve Collapse

Interventions

PROCEDURE

Batten batten graft

The batten grafts are autologous grafts from the patients' own tissue, produced from nasal septal quadrangular cartilage. This will be obtained during the septoplasty portion of the procedure. The batten graft will be used to stabilize the internal nasal valve and prevent nasal valve collapse on inspiration.

PROCEDURE

Septoplasty

A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.

PROCEDURE

Inferior Turbinate Reduction

The bilateral inferior turbinates will be surgically ablated.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • David Hiltzik, MD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2024-12-31
Completion
2025-06-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05287841 on ClinicalTrials.gov