Clinical trials: Otitis Media
Otitis Media
Study of the Hummingbird TTS™ Tympanostomy Tube System
The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under…
- Trial name
- NCT03503591
- Testing
- Hummingbird Tympanostomy Tube System
- Where
- 4 sites in United States
- Volunteers
- 109 people
- Sponsor
- Preceptis Medical, Inc.
Otitis Media
Earset Healthy Volunteer Study
The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).
- Trial name
- NCT01611246
- Testing
- Iontophoresis System With Earset
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Otitis Media
Singapore Tympanostomy Tube Delivery System Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis…
- Trial name
- NCT01046877
- Testing
- Tympanostomy Tube Delivery System
- Where
- Singapore
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation
CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.
- Conditions
- CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media, Otospongiosis, Otosclerosis
- Trial name
- CBCT-ENT (NCT01855425)
- Testing
- Radiation
- Where
- 3 sites in United States, Belgium and 1 more
- Volunteers
- 96 people
- Sponsor
- Carestream Health, Inc.
Otitis Media
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes.
- Trial name
- NCT00781521
- Testing
- ofloxacin otic solution 0.3%
- Volunteers
- 96 people
- Sponsor
- Daiichi Sankyo
Infections, Streptococcal, Streptococcus Pneumoniae
Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H.
- Trial name
- NCT00839254
- Testing
- Pneumococcal conjugate vaccine Synflorix (GSK1024850A), GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine), GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
- Where
- 15 sites in Finland
- Volunteers
- 6,181 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Otitis Media With Effusion, Middle Ear Effusion
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
The study has three objectives: 1. To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy) 2.
- Trial name
- NCT01421199
- Testing
- Myringotomy
- Volunteers
- 125 people
- Sponsor
- OtoSonics Inc.
Infections, Streptococcal
COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine
This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate vaccine (Synflorix vaccine, or GSK1024850A) to…
- Trial name
- NCT00466947
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Havrix, Engerix-B
- Where
- 22 sites in Argentina, Colombia and 1 more
- Volunteers
- 23,802 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Otitis Media
Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media
Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops.
- Trial name
- AR01006 (NCT02044341)
- Testing
- AR01, Glycerin ear drops
- Where
- 29 sites in United States
- Volunteers
- 304 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Otitis Media, Myringotomy Tube Insertion
National Trends in Otitis Media in Children Under 5 Years of Age
The rationale for this study is to assess the change in ambulatory care visit rates for acute otitis media between the period before (2001-2009) and after the introduction of the 13-valent pneumococcal conjugate vaccine (13vPnC)…
- Conditions
- Otitis Media, Myringotomy Tube Insertion, Skin Rash, Trauma
- Trial name
- NCT01339546
- Testing
- no intervention
- Volunteers
- 1 people
- Sponsor
- Pfizer
Acute Otitis Media
Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)
Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops.
- Trial name
- NCT02074007
- Testing
- AR01
- Where
- 21 sites in United States
- Volunteers
- 178 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Otitis Media Acute
Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.
- Trial name
- OTO-MATIC (NCT06285812)
- Testing
- OtoSight Middle Ear Scope
- Where
- 7 sites in United States
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- PhotoniCare, Inc.
Otitis Media With Effusion, Acute Otitis Media
Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure…
- Conditions
- Otitis Media With Effusion, Acute Otitis Media, Otitis Media
- Trial name
- NCT05915078
- Testing
- Iontophoresis and tube placement
- Where
- 6 sites in United States
- Volunteers
- 200 people
- Sponsor
- Smith & Nephew, Inc.
Otitis Media With Effusion
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
- Trial name
- NCT01949155
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Acute Otitis Media, Pneumonia
Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
The purpose of this study is to provide data on trends of morbidity due to Acute Otitis Media (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related health care resources before and after the…
- Trial name
- NCT02567747
- Testing
- Data collection
- Where
- Colombia
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Otitis Media
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear.
- Trial name
- NCT02600559
- Testing
- OTO-201 (ciprofloxacin)
- Where
- United States
- Volunteers
- 501 people
- Sponsor
- Otonomy, Inc.
Otitis Media With Effusion
Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media
The goal of the study is to investigate if the active agent of Sinuclean Nebules is efficacious in the treatment of pediatric exudative otitis media, comparing with saline.
- Trial name
- NCT02858388
- Testing
- Sinuclean Nebules 45, Saline solution
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Galsor S.r.l.
Otitis Media
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute…
- Trial name
- NCT00051753
- Testing
- levofloxacin; amoxicillin/clavulanate
- Volunteers
- 1,643 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Barotrauma;Ear, OME - Otitis Media With Effusion
Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)
A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting.
- Conditions
- Barotrauma;Ear, OME - Otitis Media With Effusion, AOM - Acute Otitis Media, Eustachian Tube Dysfunction
- Trial name
- ADEPT (NCT03197558)
- Testing
- Tymbion Iontophoresis and Tube Delivery System (TDS)
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tusker Medical
Otitis Media
Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol
To investigate the safety, tolerance, dynamic percolation model of single dose usage pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic suppurative otitis media
- Trial name
- NCT02592096
- Testing
- 0.1% Pazufloxacin Mesilate Ear Drops, 0.3% Pazufloxacin Mesilate Ear Drops, 0.5% Pazufloxacin Mesilate Ear Drops
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Lee's Pharmaceutical Limited