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Procedure

Investigational Device for Nasal Obstruction

Q: How many health care facilities are conducting this experiment?

<p>This research is being conducted at Albany ENT &#x26; <a href="https://www.withpower.com/clinical-trials/allergy">Allergy</a> Services, PC in Albany, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>; Specialty Physicians in Bethlehem, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>; Breathe Clear Institute in Torrance <a href="https://www.withpower.com/clinical-trials/california">California</a> and 8 additional sites.</p>

Verified Trial

N/A

Recruiting

Research Sponsored by Spirair, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥21 to ≤ 64 years of age at time of consent

Seeking treatment for nasal airway obstruction (NAO) symptoms due primarily to cartilaginous nasal septal deviation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial tested a new implant and delivery system to fix a deviated septum, a common breathing problem.

Who is the study for?

Adults aged 21-64 with a deviated septum causing nasal blockage, who are seeking treatment and willing to undergo an implant procedure. Participants must have significant symptoms (NOSE score ≥30), speak English, and be able to follow the study protocol. Excluded are those with prior nose surgeries, concurrent ENT procedures other than turbinate reduction, certain nasal deformities or conditions, active infections at the site of implantation, recent drug abuse history, pregnant or breastfeeding women, and anyone unable to comply with the study requirements.Check my eligibility

What is being tested?

The trial is testing a new bioabsorbable Spirair Nasal Device implanted using a special delivery system designed for people with nasal airway obstruction due to septal deviation. It's an open-label pilot study which means everyone gets the device and knows what they're receiving.See study design

What are the potential side effects?

Potential side effects may include local reactions at the implant site like swelling or infection, discomfort from the procedure itself, possible allergic reactions if sensitive to materials in the device such as poly(dioxanone), and complications related to wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 64 years old.

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I am looking for treatment because my nose is blocked due to a bent nasal septum.

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I am willing to have a nasal implant procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Effectiveness Endpoint

Primary Safety Endpoint

Secondary outcome measures

Secondary Endpoint - 1

Secondary Endpoint - 2

Secondary Endpoint - 3

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Investigational DeviceExperimental Treatment1 Intervention

Treatment with the Spirair Septal correction device and delivery system for correction of cartilaginous nasal septal deviation.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Spirair, IncLead Sponsor

Brandon McCutcheon, MDStudy DirectorSpirair, CMO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the prime aims of this experimental research?

"According to the trial sponsor, Spirair Inc., the primary outcome will be evaluated at 3 month intervals and is classified as Primary Safety Endpoint. Additionally, Secondary Endpoint-2 (Change in Sino-Nasal Outcomes Test or SNOT-22 from baseline), Secondary Endpoint -4 (Change in Nasal Airway Obstruction Visual Analog Scale or NAO VAS from baseline) and Secondary Endpoint-3( Change in Euro QOL Five Dimensions Questionnaire or EQ-5D-5L from baseline.) are being assessed as secondary outcomes."

Answered by AI

Is enrollment for this research project still open?

"According to the information from clinicaltrials.gov this experiment is actively seeking participants and began its recruitment campaign on November 1st 2023, with a most recent update published at the end of that month."

Answered by AI

What is the total cohort size for this research endeavor?

"Spirair, Inc., the financial sponsor of this research project, require a minimum of 50 eligible patients to conducted the trial. Trial sites include Albany ENT & Allergy Services in Albany and Specialty Physicians in Bethlehem."

Answered by AI

How many health care facilities are conducting this experiment?

"This research is being conducted at Albany ENT & Allergy Services, PC in Albany, New york; Specialty Physicians in Bethlehem, Pennsylvania; Breathe Clear Institute in Torrance California and 8 additional sites."

Answered by AI

Could I potentially be eligible to participate in this trial?

"This trial is currently enrolling 50 participants that are between 21 and 64 years old, who suffer from nasal obstruction."

Answered by AI

Are those beneath the age of fifty able to participate in this medical experiment?

"The minimum age of applicants accepted for this trial is 21 while the maximum is 64. There are 4 trials tailored to those below 18 and 22 that accommodate seniors above 65."

Answered by AI

Who else is applying?

What site did they apply to?

Kentuckiana Ear, Nose & Throat

Tandem Clinical Research, Marrero

The Centers for Advanced ENT Care, LLC

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

My deviated septum makes it difficult to breath through my nose, contributing, to snoring as well as making it difficult to breathe. properly during exercise.

PatientReceived no prior treatments

I wake myself up from snoring a few times per night. When I first begin to fall asleep, I can usually hear it as I drift off. I've been told that I stop breathing and gasp about once per hour while asleep. I had a home sleep study test done about 8 years ago - results were inconclusive- I've been planning to do another sleep study soon.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant

2023. "Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06163404.

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