Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05287841

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

Led by Northwell Health · Updated on 2024-09-20

96

Participants Needed

3

Research Sites

215 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Able to provide written informed consent
  • Indicated for batten graft, septoplasty, and turbinate reduction based on current surgical standards
  • Septal deviation confirmed by direct or endoscopic examination
  • Inferior turbinate hypertrophy confirmed by examination
  • Documented collapse of external nasal valve and/or lateral motion instability
  • Clinical or modified Cottle test assessment confirming external nasal valve collapse
  • Endoscopic confirmation that septal deviation, turbinate hypertrophy, and nasal valve collapse cause obstructed breathing
Not Eligible

You will not qualify if you...

  • Septal perforation
  • History of previous functional rhinoplasty or sinus or septal surgery
  • Planned concurrent aesthetic or cosmetic rhinoplasty
  • Untreated or medically unresponsive allergic rhinitis
  • Concurrent sinus surgery, nasal polyp removal, or concha bullosa resection planned

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Poplar Bluff Regional Medical Center

Poplar Bluff, Missouri, United States, 63901

Not Yet Recruiting

2

Lenox Hill Hospital/Staten Island University Hospital

New York, New York, United States, 10075

Actively Recruiting

3

Staten Island University Hospital

Staten Island, New York, United States, 10305

Actively Recruiting

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Research Team

R

Research Department

CONTACT

D

David Hiltzik, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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