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[Prøving av enhet som ikke er godkjent eller godkjent av U.S. FDA]

25. april 2026 oppdatert av: Aventix Medical Inc.
Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The NOVOCLEAR™ Device is a radiofrequency-based hand-held device intended to treat chronic rhinitis by delivering pulsed field energy to soft tissues in the nasal airway, including the posterior nasal nerve distribution. The NOVOCLEAR™ Device is used with the AVENTIX™ PFX System. The AVENTIX™ PFX System is a radiofrequency-based electrosurgical system designed to deliver non-thermal pulsed field energy to the targeted tissue.

This is a non-significant risk, prospective, multi-center, single arm study to evaluate the safety, effectiveness and tolerability of the NOVOCLEAR™ Device used with the AVENTIX™ PFX System.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80923
        • Rekruttering
        • Colorado ENT and Allergy
        • Hovedetterforsker:
          • Bryan Davis, MD
        • Ta kontakt med:
          • Monica Davis
          • Telefonnummer: (719) 867-7804
    • Mississippi
      • Ocean Springs, Mississippi, Forente stater, 39564
        • Rekruttering
        • Bay Area ENT
        • Ta kontakt med:
          • Raymond Weiss, MD
    • Texas
      • San Antonio, Texas, Forente stater, 78256
        • Rekruttering
        • Atkins Expert Sinus Care
        • Ta kontakt med:
          • James Atkins, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. The subject is 18 to 85 years of age.
  2. The subject has had symptoms of chronic rhinitis for greater than 6 months with insufficient response to nasal steroids.
  3. The subject has an rTNSS total score of ≥ 6.
  4. The subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion (rTNSS rating of 2 or 3 for rhinorrhea and 1, 2, or 3 for congestion)
  5. The subject is able and willing to provide written informed consent and comply with the protocol requirements.

Exclusion Criteria:

  1. The subject has clinically significant anatomic obstructions on either side that limit access to the posterior nose, including severe septal deviation, nasal polyps, and sinonasal tumor
  2. The subject has a septal perforation
  3. The subject has had prior sinus or nasal surgery on either side that significantly alters the anatomy of the posterior nose.
  4. The subject had had previous surgery of the PNN for chronic rhinitis.
  5. The subject has had prior head or neck irradiation
  6. The subject has an active or chronic nasal or sinus infection
  7. The subject has active coagulation disorder, or the patient is receiving anticoagulants
  8. The subject has a history of dry eye or dry nose symptoms
  9. Patient has rhinitis medicamentosa
  10. The subject has ocular allergic symptoms
  11. The subject has a history of nose bleeds
  12. The subject has electrically sensitive implants (e.g. cochlear implants, pacemakers, defibrillators)
  13. The subject is pregnant or lactating
  14. The subject is participating in another clinical research study
  15. The subject has an allergy or intolerance to anesthetic agent
  16. Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or pose an increased risk

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: NOVOCLEAR™ Device Treatment Group
Subjects treated with pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.
Enhet: NOVOCLEAR™ Device
Pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline.
Tidsramme: 90 days
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.
90 days
Proportion of subjects with device and/or procedure-related serious adverse events through 90 days
Tidsramme: 90 days
Characterization of the type and frequency of study device and/or study procedure-related adverse events reported during or following the study procedure through 90 days follow-up.
90 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean change in rTNSS at 7 days compared to baseline
Tidsramme: 7 days
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.
7 days
Mean change in rTNSS at 14 days compared to baseline
Tidsramme: 14 days
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.
14 days
Mean change in rTNSS at 30 days compared to baseline
Tidsramme: 30 days
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.
30 days
Mean change in rTNSS at 6 months compared to baseline
Tidsramme: 6 months
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.
6 months
Mean change in rTNSS at 1 year compared to baseline
Tidsramme: 1 year
The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.
1 year
Mean procedure tolerability using a Visual Analogue Scale (VAS) at post-procedure
Tidsramme: Post-procedure
Immediately after the study procedure, subjects will be asked to rate the pain they experienced in their nasal cavity(ies) during the procedure using a 100 mm visual analogue scale with 0 mm representing no pain and 100 mm representing worst pain imaginable.
Post-procedure
Subject satisfaction at 90 days
Tidsramme: 90 days

Subjects will be asked two questions regarding their satisfaction with the study procedure.

The first question asks; How satisfied with your procedure are you?; with the following five response options: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied.

The second question asks; How likely are you to refer a friend for this procedure?; with the following five response options: very likely, likely, neutral, unlikely, or very unlikely.
90 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Aventix Medical Inc.

Etterforskere

  • Hovedetterforsker: Raymond Weiss, MD, Bay Area ENT

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. november 2024

Primær fullføring (Antatt)

1. april 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

13. september 2024

Først innsendt som oppfylte QC-kriteriene

13. september 2024

Først lagt ut (Faktiske)

19. september 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. april 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A2024-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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