NCT04296448 is a NA clinical trial of Cellscope in Ear Infection, sponsored by Johns Hopkins University.

Who is sponsoring NCT04296448?

NCT04296448 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT04296448?

Interventions in NCT04296448: Cellscope.

What condition does NCT04296448 study?

NCT04296448 studies Ear Infection, Pediatric Disease, Acute Otitis Media.

Is NCT04296448 still recruiting?

NCT04296448 is currently completed. Last updated 26 August 2021.

Are results published for NCT04296448?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-08-26 · How we verify

NCT04296448

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of Cellphone Based Otoscopy in Pediatric Patients

Completed NA Results posted Last updated 26 August 2021

What this trial tests

NA trial testing Cellscope in Ear Infection in 197 participants. Completed in 1 March 2020.

Timeline

1 September 2019

Primary endpoint
1 March 2020

1 March 2020

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	197
Start date	1 September 2019
Primary completion	1 March 2020
Estimated completion	1 March 2020
Sites	1 location across United States

Drugs / interventions tested

Cellscope

Conditions studied

Ear Infection — all drugs for Ear Infection →
Pediatric Disease — all drugs for Pediatric Disease →
Acute Otitis Media — all drugs for Acute Otitis Media →

Sponsor

Johns Hopkins University

Who can join

Eligibility, any sex, with Ear Infection or Pediatric Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic Primary · 6 months

Concordance of trainee and supervisor utilizing the OMgrade scale, between traditional otoscope and cellscope. Concordance is determined by the concordance-statistic (0-1) in a logistic regression model. The closer the number is to 1 the higher the concordance.

Group	Value	95% CI
Traditional Otoscope	0.64	0.57 – 0.70
Cellscope	0.75	0.69 – 0.81

Interrater Reliability as Assessed by a Kappa Statistic Secondary · 6 months

Kappa statistic (Fleiss' Kappa) of trainee and supervisor utilizing the OMgrade scale. The kappa statistic ranges from 0-1. The closer the number is to 1 the higher the agreement.

Group	Value	95% CI
Traditional Otoscope	0.37	0.24 – 0.51
Cellscope	0.67	0.57 – 0.78

Number of Patients Who Receive Antibiotics Secondary · 6 months

Number of patients who receive antibiotics between traditional otoscope and cellscope.

Group	Value	95% CI
Traditional Otoscope	21
Cellscope	11

Number of Participants Who Receive a Repeat Examination Secondary · 6 months

Number of participants who receive a repeat examination between traditional otoscope and cellscope.

Group	Value	95% CI
Traditional Otoscope	94
Cellscope	25

Sponsor's own description

The Cellscope is an iPhone-based otoscope that uses the iPhone camera and light source to capture HIPAA compliant images and video recordings of the external and middle ear structure. This technology allows multiple providers, at different levels of training, the ability to simultaneously exam a child's external and middle ear structures. The investigators hypothesize this device will result in improved concordance in trainee/supervisor exam findings, increase trainee confidence in exam findings, decreased antibiotic prescriptions, and fewer repeat exams by multiple providers. Thus, this study has the potential to improve physician training and examination confidence, decrease the unnecessary use of antibiotics, and improve the patient/caregiver experience in healthcare interactions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Ear Infection

Currently open trials in the same condition.

NCT05641285 — Diagnostic Utility of Otosight Middle Ear Scope · active not recruiting
NCT06429709 — Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM · active not recruiting

Other Johns Hopkins University trials

Trials by the same sponsor.

NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04296448 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 26 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04296448.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing