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New treatment option for Nasal Obstruction
Official title Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
ClinicalTrials.gov ID: NCT05287841
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Poplar Bluff, Missouri, United States
- New York, New York, United States
- Staten Island, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poplar Bluff, Missouri, United States; New York, New York, United States; Staten Island, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.