Middle Turbinate Medialization

Clinical Trial Title

A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of TurbAlign™ to Achieve Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery (FESS) (GAIA)

National Clinical Trial Number:

NCT07027267

Contact Information

Mahendra Shah, MD

Clinical Trial Protocol Description:

A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are between 18 and 70 years of age at time of consent.
  • Are scheduled to undergo bilateral endoscopic sinus surgery.
  • Are able to speak, read and understand English.
  • Are willing and able to provide informed consent and comply with the study protocol.

You will be excluded from the study if any of the following criteria apply to you:

  • Have a history of removal of one or both middle turbinates.
  • Have chronic nasal decongestant use (i.e. Afrin, etc).
  • Have recreational intra-nasal drug use within 12 months of enrollment.
  • Have documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Pete Batra, MD

Contact Information

Mahendra Shah, MD

Clinical Trial Location

Rush University Medical Center

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

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