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Batten Grafting for Nasal Valve Collapse
N/A
Recruiting
Led By David Hiltzik, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
Study Summary
This trial is testing whether adding a batten graft to septoplasty and turbinate reduction surgery leads to better results than septoplasty and turbinate reduction surgery alone.
Who is the study for?
This trial is for adults over 18 with breathing obstruction due to a deviated septum, enlarged turbinates, and external nasal valve collapse. Candidates must be able to consent and have these conditions confirmed by clinical examination. It's not for those with septal perforation, untreated/unresponsive allergic rhinitis, past nose surgeries, or concurrent sinus/polyp surgery.Check my eligibility
What is being tested?
The study tests if adding batten grafts to standard septoplasty and turbinate reduction improves nasal airflow more effectively than the standard procedure alone. Participants will be divided into two groups: one receiving the combined treatment (intervention arm) and one receiving only the standard treatment (control arm).See study design
What are the potential side effects?
Potential side effects may include discomfort at the graft site, swelling, bleeding, infection risk post-surgery, possible adverse reaction to anesthesia during surgical procedures, and complications related to healing that could affect breathing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with swollen nasal passages.
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I need surgery to correct my nasal passage according to standard practices.
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My breathing issues are due to septal deviation, turbinate hypertrophy, and external nasal valve collapse.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nasal obstruction present finding
Secondary outcome measures
Complications and side-effects
Cost-effectiveness (EQ-5D-5L)
Lateral Wall Insufficiency (LWI) scores
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Batten graft, plus septoplasty and inferior turbinate reductionExperimental Treatment3 Interventions
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.
Group II: Septoplasty and inferior turbinate reduction aloneActive Control2 Interventions
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.
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,837 Total Patients Enrolled
David Hiltzik, MDPrincipal InvestigatorNorthwell Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am chosen for a nose job at the same time as my other procedure.I have been diagnosed with swollen nasal passages.Your nose may be checked by looking for a collapse when you breathe in or by performing a Modified Cottle test.I need surgery to correct my nasal passage according to standard practices.You need to have a deviated septum seen during a direct or endoscopic examination.You have a documented problem with the structure or movement of your nose.I have a hole in the wall dividing my nostrils.I have untreated or treatment-resistant allergic rhinitis.My breathing issues are due to septal deviation, turbinate hypertrophy, and external nasal valve collapse.I have had surgery on my nose or sinuses before.I am 18 years old or older.I am having or have had surgery for sinus issues or polyp removal.
Research Study Groups:
This trial has the following groups:- Group 1: Batten graft, plus septoplasty and inferior turbinate reduction
- Group 2: Septoplasty and inferior turbinate reduction alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for those wishing to participate in this experiment?
"Confirmed. The clinicaltrials.gov page displays that this trial, which was initially published on April 30th 2021, is still actively recruiting participants. Up to 96 individuals need to be sourced from 3 separate medical facilities."
Answered by AI
What is the capacity for participants in this experiment?
"Affirmative, the clinical trial is still in need of participants. The study was first listed on April 30th 2021 and edited most recently on March 11th 2022. 96 patients must be enrolled from 3 different sites."
Answered by AI
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