Clinical trials: Middle Ear Effusion
Otitis Media With Effusion in Children, Otitis Media Recurrent
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
- Trial name
- NCT02436304
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Volunteers
- 404 people
- Sponsor
- Alcon Research
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.
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 With Effusion
Clinical Study of the Tympanostomy Tube Delivery System
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such…
- Trial name
- inVENT (NCT00939796)
- Testing
- Acclarent Tympanostomy Tube Delivery System
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Integra LifeSciences Corporation
OME - Otitis Media With Effusion, AOM - Acute Otitis Media
In-Office Tympanostomy Tube Placement in Children (OTTER)
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
- Trial name
- OTTER (NCT03323736)
- Testing
- Iontophoresis & tube placement, Tube placement
- Where
- 19 sites in United States, Canada
- Volunteers
- 370 people
- Sponsor
- Tusker Medical
Bilateral Middle Ear Effusion
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement.
- Trial name
- NCT02350998
- Testing
- OTO-201
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- Otonomy, 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
- NCT01949142
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Otitis Media With Effusion in Children, Otitis Media Recurrent
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
- Trial name
- NCT02539654
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Alcon Research
Otitis Media With Effusion in Children, Otitis Media Recurrent
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
- Trial name
- NCT02432105
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Volunteers
- 470 people
- Sponsor
- Alcon Research
Otitis Media With Effusion, Acute Otitis Media
Evaluation of the Tympanostomy Tube Delivery System
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
- Trial name
- inVENT-OR (NCT01202578)
- Testing
- tympanostomy tube
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Integra LifeSciences Corporation