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EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults

18 agosto 2026 aggiornato da: Philip Perez

This study evaluates the use of the EarFlo device in adults with clinically confirmed Eustachian tube dysfunction and/or otitis media with effusion. The purpose of the study is to assess the safety, tolerability, and short-term effects of device use on ear pressure symptoms and middle ear function.

Participants will complete a brief symptom questionnaire, undergo routine ear examinations and testing, and use the EarFlo device once during a clinic visit. Ear examination and testing will be repeated after device use to evaluate any short-term changes. This study involves a single study visit and does not include any surgical or invasive procedures.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Otitis media with effusion (OME) is a condition characterized by the presence of fluid in the middle ear and may occur in both children and adults. Eustachian tube dysfunction (ETD) is commonly associated with OME and may contribute to symptoms such as ear fullness, pressure, muffled hearing, and discomfort due to impaired ventilation of the middle ear.

The EarFlo device is designed to promote Eustachian tube opening during swallowing. The EarFlo device has been previously evaluated in pediatric populations with otitis media with effusion and is FDA-cleared for its intended use.This study aims to evaluate the safety, tolerability, and short-term effects of the EarFlo device in an adult population diagnosed with OME and/or ETD.

This is a prospective, single-visit, non-randomized interventional study evaluating the safety, tolerability, and short-term effects of the EarFlo device in adults with otitis media with effusion (OME) and/or Eustachian tube dysfunction (ETD). The study focuses on short-term changes in subjective symptoms and objective middle ear findings following a single supervised use of the device in a clinical setting.

Eligible participants will attend one study visit. At baseline, participants will complete a validated symptom questionnaire and undergo routine otologic evaluation, including otoscopic examination and tympanometry, as clinically appropriate. Otoscopic images of the tympanic membrane and middle ear will be captured prior to device use.

Participants will then receive instruction on proper use of the EarFlo device from trained study personnel. The device will be used once during the visit while the participant drinks a liquid of their choice. Device use is noninvasive and does not involve surgical procedures or sedation.

Following device use, participants will repeat middle ear assessments, including tympanometry and otoscopic examination. Post-use otoscopic images will be captured and compared with baseline images. Otoscopic images will be reviewed and categorized as improved or not improved by a physician who is blinded to the timing of image acquisition (pre- or post-device use).

The primary objectives of this study are to evaluate the safety, tolerability, and short-term effects of the EarFlo device in adults and to obtain preliminary estimates of its short-term effects on ear pressure symptoms and middle ear findings following a single supervised use. As a single-arm pilot study, the findings are intended to inform the design of future controlled studies. No long-term follow-up is required.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15219
        • UPMC Mercy
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • UPMC Shadyside
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • UPMC Montefiore
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Eye and Ear Institute / UPMC Presbyterian

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Adults aged 18 years and older.
  • Adults with confirmed Otitis Media with Effusion (OME) diagnosis with clinical assessment.
  • Adults with confirmed dilatory ETD (Eustachian Tube Dysfunction) on clinical assessment.
  • Willingness to refrain from initiating new treatments for OME/ETD (e.g., new surgical or device treatments, tympanostomy tubes) during the study period. Standard care will not be refrained if needed.

Exclusion Criteria:

  • Presence of acute otitis media, ear infection, or otorrhea within the past 4 weeks.
  • Any medical, psychiatric, or cognitive condition that, in the opinion of the investigators, would interfere with study participation or compliance.
  • Inability to use the EarFlo device as instructed (e.g., due to severe nasal obstruction, craniofacial anomalies, or neuromuscular disorders).
  • Recent eye, ear or nose surgeries or ear trauma. (<4 weeks)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: EarFlo Intervention Arm
Participants in this single arm will undergo baseline assessments, use the EarFlo device once during a clinic visit, and complete post-use assessments to evaluate short-term changes in ear symptoms and middle ear function.
Dispositivo: EarFlo Device
The EarFlo device is a non-invasive, cup-based device used during swallowing to help equalize middle ear pressure. By delivering a controlled puff of air through the nose during swallowing, it assists Eustachian tube opening to relieve negative middle ear pressure. Participants will use the device once during a single clinic visit while drinking water or a beverage of their choice. No surgery or invasive procedures are involved.
Altri nomi:
  • Earflo (Model EF001)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in middle ear pressure and compliance measured by tympanometry following single use of the EarFlo device
Lasso di tempo: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
Change in middle ear pressure measured using tympanometric peak pressure (daPa) immediately before and immediately after a single supervised in-clinic use of the EarFlo device. Tympanometric peak pressure values will be compared to evaluate short-term changes in middle ear function. More positive values indicate improved middle ear pressure equalization.
Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
Blinded otoscopic image assessment of middle ear effusion before and after EarFlo device use
Lasso di tempo: Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit
Otoscopic images obtained immediately before and immediately after EarFlo device use will be independently reviewed by a blinded physician. Images will be classified as improved or not improved based on predefined evidence of middle ear effusion and tympanic membrane appearance.
Immediately before EarFlo device use (baseline) and immediately after EarFlo device use (post-intervention) during the single study visit

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence, severity, and relatedness of adverse events
Lasso di tempo: From initiation of EarFlo device use through the end of the single study visit, up to 30 minutes.
Safety and tolerability of the EarFlo device in Adults will be assessed based on the number and percentage of participants experiencing adverse events. Adverse events will be summarized according to incidence, severity, and relationship to the EarFlo device or study procedure.
From initiation of EarFlo device use through the end of the single study visit, up to 30 minutes.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Philip Perez

Collaboratori

Earflo Inc.

Investigatori

  • Investigatore principale: Philip L Perez, MD, University of Pittsburgh

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

27 agosto 2026

Completamento primario (Stimato)

30 novembre 2027

Completamento dello studio (Stimato)

15 maggio 2028

Date di iscrizione allo studio

Primo inviato

21 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 agosto 2026

Primo Inserito (Effettivo)

20 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY25050186

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

There is no current plan to share individual participant data (IPD). Any future data sharing would require separate review and approval and would be conducted in accordance with institutional policies and applicable regulations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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