Birmingham, ALNCT07290140Now EnrollingIRB Ready

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps Clinical Trial in Birmingham, AL

Access cutting-edge chronic rhinosinusitis (crs) with and without nasal polyps treatment through this clinical trial at a research site in Birmingham. Study-provided care at no cost to qualified participants.

Sponsored by Airiver Medical, Inc.

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Expert Care in Birmingham

Access chronic rhinosinusitis (crs) with and without nasal polyps specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related chronic rhinosinusitis (crs) with and without nasal polyps treatment provided free

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Check if you qualify for this chronic rhinosinusitis (crs) with and without nasal polyps clinical trial in Birmingham, AL

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Why Participate?

  • No-Cost Study Care

  • Local to Birmingham

    Convenient for AL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Birmingham site if eligible
  4. 4Begin participation

About This Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps Study in Birmingham

This is a prospective, multicenter, randomized, controlled, double-blind clinical trial enrolling 300 adult subjects with chronic rhinosinusitis (CRS) with and without nasal polyps (CRSwNP and CRSsNP) indicated for endoscopic sinus surgery (ESS).

Sponsor: Airiver Medical, Inc.

Who Can Participate

Inclusion Criteria

Male or female, aged ≥18 years
Confirmed diagnosis of CRS per the 2021 "International Consensus Statement on Allergy and Rhinology: Rhinosinusitis" definition.
Radiographic evidence of bilateral ethmoid disease on CT taken 6 months or less prior to study index procedure and at least 6 months after any prior ESS or nasal surgery, polypectomy, balloon sinus dilation, etc. as applicable
Radiographic evidence of bilateral frontal sinus and/or frontal sinus outflow tract disease
Baseline SNOT-22 score ≥ 30
Has failed previous medical treatment and is an appropriate candidate for primary or revision ESS of bilateral ethmoid sinuses and bilateral frontal/frontal sinus outflow tract
Willing and able to provide written informed consent
Willing and able to comply with all protocol follow up visits and assessments

Exclusion Criteria

Nasal cavity tumor (malignant or benign)
Antrochoanal polyps
Previous complete middle turbinate resection
Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
History of prior lamina dehiscence or cerebrospinal fluid (CSF) leak in skull-based dehiscence
Concurrent condition requiring active chemotherapy and/or immunotherapy management
Subjects whose symptoms are too severe to undergo ESS (e.g., temperature \>102.5F or extra-sinus manifestations, such as orbital cellulitis; dental or facial or brain abscess; cavernous vein thrombosis; or altered mental status
History of complications from prior ESS or balloon dilation procedure (e.g., CSF leak or injury to the skull base or orbital injury)
History of primary ciliary dyskinesia
Oral-steroid dependent conditions such as chronic obstructive pulmonary disease (COPD) or other conditions
Have evidence of significant baseline mucosal injury, ulceration, or erosion (e.g., exposed cartilage, perforation) on nasal examination
Acute purulent nasal infection or upper respiratory tract infection, including but not limited to acute bacterial rhinosinusitis (ABRS), acute rhinosinusitis (ARS), or COVID -19 within 2 weeks before the baseline visit.
Allergy or hypersensitivity to paclitaxel or structurally related compounds.
Subject has taken biologic drugs in the 6 months leading up to the screening visit or who expect to take biologics in the next 24 months.
Subject has taken oral corticosteroids in the 30 days leading up to their baseline appointment.
Subject who plans to undergo posterior nasal nerve ablation in the next 24 months.
Subject has a history of inability to tolerate nasal endoscopy
Concurrent medical condition that would affect the investigator's ability to evaluate the subject's condition or that could compromise subject safety, such as severe COPD, severe asthma
Pregnant or planning to become pregnant during the first 12 months of enrollment in the study
Subject who has undergone a nasal/sinus surgery including but not limited to ESS, polypectomy, septoplasty, turbinoplasty, balloon sinus dilation, placement of steroid releasing implants, posterior nasal nerve ablation in the 6 months prior to the baseline appointment.
Previous Draf III frontal sinus surgery or a study index procedure ESS is expected to be or is a Draf III sinus surgery.
Subject whose index procedure did not include bilateral ethmoid ESS and bilateral frontal ESS
Subject whose expected study index procedure includes steroid releasing implants or non-resorbable nasal packing/stents.
Subject whose study index procedure is aborted for any reason
Life expectancy \<2 years

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Birmingham?

Yes, this clinical trial (NCT07290140) has an active research site in Birmingham, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps Treatment Options in Birmingham, AL

If you're searching for chronic rhinosinusitis (crs) with and without nasal polyps treatment options in Birmingham, AL, this clinical trial (NCT07290140) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Birmingham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic rhinosinusitis (crs) with and without nasal polyps specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic rhinosinusitis (crs) with and without nasal polyps clinical trials near you to find additional studies recruiting in your area.

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