TurbAlign for Sinus Surgery
(Gaia Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new implant called TurbAlign, designed to assist with sinus surgery. The goal is to determine if this implant can effectively separate parts of the nasal area to aid recovery after surgery. It is ideal for those scheduled for sinus surgery soon and who have not had any major nasal issues or surgeries before. Frequent use of nasal sprays or recent nasal drug use may disqualify participation. As an unphased trial, this study offers a unique opportunity to contribute to innovative research in sinus surgery recovery.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude people who use nasal decongestants regularly. It's best to discuss your specific medications with the trial team.
What prior data suggests that the TurbAlign device is safe for sinus surgery?
Research shows that the FDA has cleared the TurbAlign implant for use in sinus surgery. This clearance indicates that the device meets specific safety standards. The TurbAlign is a bioabsorbable implant, meaning it breaks down in the body, and it is designed to aid healing by stabilizing nasal structures after surgery.
In earlier studies, researchers used TurbAlign to help position the middle turbinate, a part inside the nose, and patients generally tolerated it well. There were no major reports of serious side effects, suggesting the implant is safe for use in people, although individual experiences may differ. It is important to consult a doctor to understand the potential risks and benefits for your situation.12345Why are researchers excited about this trial?
TurbAlign is unique because it uses the Spirair device to specifically target the medialization of the middle turbinates during sinus surgery. Unlike traditional treatments for nasal obstruction, which might include medications like nasal steroids or surgical procedures such as turbinate reduction, TurbAlign focuses on repositioning the turbinates more precisely. This novel approach could potentially offer better outcomes by improving airflow and reducing nasal blockage more effectively. Researchers are excited because this method might lead to quicker recovery times and improved comfort for patients undergoing sinus surgery.
What evidence suggests that the TurbAlign device is effective for sinus surgery?
Research has shown that the TurbAlign implant aids sinus surgery by stabilizing the middle turbinate. In one study, 70% of patients in one group and 80% in another experienced complete symptom relief, with no recurrence of sinusitis. The implant dissolves in the body over time, eliminating the need for removal. The FDA has approved TurbAlign, confirming its safety and effectiveness for holding the middle turbinate after surgery. These findings suggest that TurbAlign can be a reliable choice for enhancing sinus surgery outcomes.12356
Are You a Good Fit for This Trial?
This trial is for individuals who have undergone functional endoscopic sinus surgery and are experiencing turbinate hypertrophy, which can cause nasal obstruction. Specific eligibility criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Spirair device for medialization of the middle turbinates
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TurbAlign
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spirair, Inc
Lead Sponsor