NCT05287841 · Northwell Health
Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
What this study is about
The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention treatment group$1) compared to septoplasty and turbinate reduction alone (control treatment group$1), both in terms of subjective and objective assessments.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients should satisfy all the following criteria to be considered eligible for randomization:
- Be age 18 or above
- Able to provide written informed consent
- Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices. <!-- -->
- Septal deviation must be present on direct or endoscopic examination
- Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
- Collapse of external nasal valve and/or lateral motion instability must be documented <!-- -->
- 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
- Septal perforation
- History of previous functional rhinoplasty or sinus or septal surgery
- Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty
- Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
- Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection
Where
- Poplar Bluff, Missouri
- New York, New York
- Staten Island, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 20, 2024 · Source of record for eligibility and locations