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

18 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Pennsylvania
      • Pittsburgh, Pennsylvania, États-Unis, 15219
        • UPMC Mercy
      • Pittsburgh, Pennsylvania, États-Unis, 15232
        • UPMC Shadyside
      • Pittsburgh, Pennsylvania, États-Unis, 15213
        • UPMC Montefiore
      • Pittsburgh, Pennsylvania, États-Unis, 15213
        • Eye and Ear Institute / UPMC Presbyterian

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Autres noms:
  • Earflo (Model EF001)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in middle ear pressure and compliance measured by tympanometry following single use of the EarFlo device
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence, severity, and relatedness of adverse events
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Philip Perez

Collaborateurs

Earflo Inc.

Les enquêteurs

  • Chercheur principal: Philip L Perez, MD, University of Pittsburgh

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

27 août 2026

Achèvement primaire (Estimé)

30 novembre 2027

Achèvement de l'étude (Estimé)

15 mai 2028

Dates d'inscription aux études

Première soumission

21 juillet 2026

Première soumission répondant aux critères de contrôle qualité

18 août 2026

Première publication (Réel)

20 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STUDY25050186

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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