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New treatment option for Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Official title Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
ClinicalTrials.gov ID: NCT07290140
What this study is testing
What is Airiver ESSpand DCB?
Airiver ESSpand DCB is an investigational medicine, being studied as a potential treatment for chronic rhinosinusitis (crs) with and without nasal polyps.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
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
You may be able to join if
- 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...
- Radiographic evidence of bilateral frontal sinus and/or frontal sinus outflow tract disease
- Baseline SNOT-22 score ≥ 30
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
- people 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
- Cedar Rapids, Iowa, United States
- Louisville, Kentucky, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Charlottesville, Virginia, 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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Diego, California, United States; Colorado Springs, Colorado, United States; Cedar Rapids, Iowa, United States; Louisville, Kentucky, United States; Philadelphia, Pennsylvania, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.