Recruiting

Batten Grafting

Sponsor:

Northwell Health

Code:

NCT05287841

Conditions

Nasal Obstruction

Septal Defect

Allergic Rhinitis

Nasal Polyps

Nasal Valve Collapse

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Batten batten graft

Septoplasty

Inferior Turbinate Reduction

Study Details

Brief 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

Study ID

NCT05287841

Start date

Apr 30, 2021

Status verified date

Sep, 2024

Completion date

Jun 15, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients should satisfy all the following criteria to be considered eligible for randomization:

1. Be age 18 or above
2. Able to provide written informed consent
3. Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices.

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1. Septal deviation must be present on direct or endoscopic examination
2. Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
3. Collapse of external nasal valve and/or lateral motion instability must be documented

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1. The ENV maye be assessed clinically by observing the alar collapse at baseline or with forced inspiration, Modified cottle may also be performed.

In all patients, endoscopic examination should document that the (a) septal deviation, (b) turbinate hypertrophy, and (c) external nasal valve collapse are the primary contributing factors of obstructed breathing.

Exclusion Criteria:

1. Septal perforation
2. History of previous functional rhinoplasty or sinus or septal surgery
3. Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty
4. Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
5. Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Batten graft, plus septoplasty and inferior turbinate reduction

In the intervention arm, a portion of the quadrangular cartilage of the nasal septum is also removed, but will be refashioned and re-implanted into the patient as an autologous batten graft. This will be performed together with standard septoplasty and turbinate reduction.

active comparator: Septoplasty and inferior turbinate reduction alone

In the control arm, a portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty and turbinate reduction.

Interventions

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.

Septoplasty

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

Inferior Turbinate Reduction

The bilateral inferior turbinates will be surgically ablated.

Primary outcome measure

  • Nasal Obstruction Symptom Evaluation (NOSE) score [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Lenox Hill Hospital/Staten Island University Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Principal Investigator:

David Hiltzik, MD

Staten Island University Hospital

Recruiting

Staten Island, New York, United States, 10305

Contacts

Principal Investigator:

David Hiltzik, MD

More Information

Sponsor

Northwell Health

Last update posted

Sep 20, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2024-09-20.