Evidence map›Paper›PMID 33616224›Full record

Trial reportThe Laryngoscope2021

Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study.

Randall A Ow, Ellen M O'Malley, Joseph K Han, Kent K Lam, David M Yen

Registry-linked trialOpen access · hybridAbstract readClinical TrialComparative StudyMulticenter Study
In one paragraph

Trial report in The Laryngoscope, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03181594 (Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03181594 nacompletednot on this map

Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis

TypeinterventionalSponsorArrinex, Inc.Ran2017 to 2020Enrolled100ConditionsChronic RhinitisArmsClariFix Device
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Safety and efficacy of cryotherapy on chronic rhinitis: a systematic review and meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Pooled it
  2. Cryoablation for the treatment of chronic rhinitis: a systematic review.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale · 2023
    Pooled it
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  6. Posterior Nasal Neurectomy for Allergic and Non-Allergic Rhinitis: Efficacy, Safety, and Predictive Factors.ORL; journal for oto-rhino-laryngology and its related specialties · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Randall A OwSacramento Ear, Nose, and Throat, Roseville, CA, U.S.A.
Ellen M O'MalleyClinical Affairs, Stryker ENT, Plymouth, MN, U.S.A.ORCID 0000-0002-3751-764X
Joseph K HanOtolaryngology, Eastern Virginia Medical School, Norfolk, VA, U.S.A.
Kent K LamOtolaryngology, Eastern Virginia Medical School, Norfolk, VA, U.S.A.
David M YenSpecialty Physician Associates, Bethlehem, PA, U.S.A.
Eastern Virginia Medical School · USBethlehem Area School District · USCarolina Ear, Nose and Throat Clinic · USStryker (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectives/hypothesisTo assess the long-term (12-24 months) safety and effectiveness of cryoablation of the posterior nasal nerve as treatment for chronic rhinitis. STUDY

designA multicenter, prospective, single-arm clinical study.

methodsThe study was conducted from February 2017 to April 2020. Study endpoints included change from baseline in the reflective Total Nasal Symptom Score (rTNSS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), physician assessment of improvement using the Clinical Global Impression-Improvement (CGI-I), and the incidence of treatment-related adverse events.

resultsNinety-one participants completed the study through the initial 12-month study period. Sixty-two participants consented to the long-term follow-up with 57 completing the 24-month follow-up. Significant improvements in the total rTNSS were reflected in a median change from baseline of -3.0 or -4.0 at all timepoints (P < .001). Greater than 80.0% of participants achieved the minimum clinically important difference (MCID) of improvement by ≥1 point on the rTNSS at all follow-ups. Total RQLQ scores indicated significant improvement (P < .0001) in quality of life. Over 77% of participants achieved the MCID (≥0.5 points) for the total RQLQ score. According to the CGI-I, ≥83.0% experienced improvement at all but the 12-month visit (61.9%). One participant experienced two treatment-related serious adverse events (epistaxis and retained pledget). A total of 29 nonserious treatment-related AEs were reported in 23 participants; most events were transient and resolved with little to no intervention.

conclusionsCryotherapy significantly and clinically improves rhinitis symptoms and quality of life with outcomes that are durable through 24 months after treatment. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:1952-1957, 2021.

Indexed as

AdultAgedChronic DiseaseCryosurgeryFemaleFollow-Up StudiesHumansMaleMiddle AgedNasal MucosaProspective StudiesQuality of LifeRhinitisSafetySurveys and QuestionnairesTreatment OutcomeAllergic rhinitischronic rhinitiscryotherapynonallergic rhinitisposterior nasal nerve cryoablation

Identifiers

PMID33616224
PMCPMC8451775
OpenAlexW3133130623

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.