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New sinus implant aims to unblock noses and ease facial pain

NCT ID NCT05295459

Symptom relief Sponsor: Lyra Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental implant called LYR-210 in 182 adults with long-term sinus inflammation (chronic rhinosinusitis). The goal was to see if it could reduce key symptoms like nasal congestion, discharge, and facial pain better than a placebo. Participants received the implant in a doctor's office and were followed for 24 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

182 people

The number who actually took part.

Started

May 2022

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 * Diagnosed as having CRS * Bilateral ethmoid disease confirmed on CT * Mean 3 cardinal symptom (3CS) score * Undergone at least 2 trials of medical treatments in the past * Has been informed of the nature of the study and provided written informed consent * Agrees to comply with all study requirements * If currently on a waiting list for sinonasal surgery, willing to be removed from the waiting list or have preplanned surgery date cancelled for the duration of the study. \[Note: this does not preclude a participant from receiving or being recommended for sinonasal surgery as rescue treatment during the study\]. Exclusion Criteria: * Inability to tolerate topical anesthesia * Previous nasal surgery * Presence of nasal polyp grade 2 or higher * Seasonal allergic rhinitis * Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids * Severe asthma * History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis * Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy * Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT * Known history of hypersensitivity or intolerance to corticosteroids * Known history of hypothalamic pituitary adrenal axial dysfunction * Previous pituitary or adrenal surgery * Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit. * Past or present acute or chronic intracranial or orbital complications of CRS * History or diagnosis (in either eye) of glaucoma or ocular hypertension * Past or present functional vision in only 1 eye * Past, present, or planned organ transplant or chemotherapy with immunosuppression * Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection * Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening * Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments * Currently participating in an investigational drug or device study * Determined by the investigator as not suitable to be enrolled

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis (diagnosis) Chronic sinusitis

Contacts and locations

Locations

  • "Farma-Med." Kujawskie Centrum Medyczne Sp. z o.o.

    Inowrocław, Poland

  • Breathe Clear Institute

    Torrance, California, 90503, United States

  • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106, Hungary

  • Budapesti Uzsoki Utcai Korhaz

    Budapest, 1145, Hungary

  • Carolina Ear, Nose, & Throat Clinic/CENTRI, Inc.

    Orangeburg, South Carolina, 29118, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Colorado ENT and Allergy

    Colorado Springs, Colorado, 80909, United States

  • Columbia University

    New York, New York, 10032, United States

  • Diagnostic and Consulting Center Mladost - Varna

    Varna, Bulgaria

  • ENT Associates of Texas

    McKinney, Texas, 75070, United States

  • ENT and Allergy Associates - White Plains

    White Plains, New York, 10605, United States

  • ENT and Allergy Associates of Florida

    Port Saint Lucie, Florida, 34952, United States

  • ENT and Allergy Associates of Florida - Brandon

    Brandon, Florida, 33511, United States

  • ENT and Allergy Associates of Florida - Plantation - Dr. Johnson

    Plantation, Florida, 33324, United States

  • ENT and Allergy Associates of Florida - Plantation - Dr. Wright

    Plantation, Florida, 33324, United States

  • ENT and Allergy Associates, LLP - Fifth Avenue New York

    New York, New York, 10016, United States

  • Ear, Nose and Throat Associates of South Florida, P.A.

    Boynton Beach, Florida, 33426, United States

  • Eszak-Pesti Centrumkorhaz - Honvedkorhaz

    Budapest, 1134, Hungary

  • HNO Landsberg

    Landsberg, Germany

  • HNO Praxis Dr. Andrea Kienle-Gogolok

    Baden, 76669, Germany

  • HNO Zentrum am Kudamm

    Berlin, Germany

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Keck School of Medicine at USC Medical Center

    Arcadia, California, 91007, United States

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    Tatabánya, Hungary

  • Lyra Investigational Site

    Ogden, Utah, 84405, United States

  • Lyra Investigational Site

    Richmond, Virginia, 23235, United States

  • Lyra Investigational Site

    Nyíregyháza, Hungary

  • Lyra Investigational Site

    Warsaw, 03-242, Poland

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114, United States

  • Mazowiecki Szpital Brodnowski Sp. z o.o. - Zespol Oddzialow Otolaryngologii

    Warsaw, 02-507, Poland

  • Military Medical Academy Multiprofile Hospital

    Sofia, Bulgaria

  • Novak Clinical Trials

    Tucson, Arizona, 85741, United States

  • Panstwowy Instytut Medyczny MSWiA - Klinika Otolaryngologii

    Wroclaw, 53-149, Poland

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, Hungary

  • Promed P.Lach R.Glowacki Spolka Jawna

    Krakow, 31-411, Poland

  • Regional Head & Neck Consulting - SENTA Clinic

    San Diego, California, 92108, United States

  • Sacramento Ear Nose and Throat Surgical and Medical Group, Inc

    Roseville, California, 95661, United States

  • Semmelweis Egyetem - Nyaksebeszeti Klinika

    Budapest, 1083, Hungary

  • Sensa Health Clinical Research

    Los Angeles, California, 90006, United States

  • Sleepmedica

    Bialystok, Poland

  • St Louis University

    St Louis, Missouri, 63104, United States

  • Szent Imre Korhaz

    Budapest, 1115, Hungary

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois, 60637, United States

  • UMHAT Kaspela Ltd

    Plovdiv, Bulgaria

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, Germany

  • Universitaire Ziekenhuizen Leuven

    Leuven, Belgium

  • University Hospital Gent

    Ghent, Belgium

  • University Multiprofile Hospital for Active Treatment

    Burgas, Bulgaria

  • University of California - Davis

    Sacramento, California, 95817, United States

  • University of California - Irvine Medical Center

    Orange, California, 92868, United States

  • University of Kansas Medical Center (KUMC)

    Fairway, Kansas, 66205, United States

  • University of Missouri-Columbia

    Columbia, Missouri, 65212, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • Velocity Lublin

    Lublin, 20-362, Poland

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