In-Office Tympanostomy Tube Placement in Children (OTTER)

PHASE3CompletedINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

October 31, 2017

Primary Completion Date

February 28, 2019

Study Completion Date

March 25, 2021

Conditions
OME - Otitis Media With EffusionAOM - Acute Otitis Media
Interventions
COMBINATION_PRODUCT

Iontophoresis & tube placement

Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement.

DEVICE

Tube placement

Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.

Trial Locations (19)

10032

Columbia University Medical Center, New York

12206

Albany ENT & Allergy Services, Albany

18017

Specialty Physician Associates, Bethlehem

28105

Charlotte Ear Eye Nose & Throat Associates, PA, Charlotte

29078

South Carolina Ear Nose and Throat, Lugoff

29118

Carolina Ear Nose and Throat Clinic, Orangeburg

32207

Nemour's Children's Specialty Care, Jacksonville

33316

South Florida Pediatric Otolaryngology, Fort Lauderdale

40207

Advanced ENT & Allergy, Louisville

75033

Frisco ENT for Children, Frisco

75034

Collin County ENT, Frisco

78240

Ear Medical Group, San Antonio

79601

Ear Nose and Throat Specialists of Abilene, Abilene

92008

California Head and Neck Specialists, Carlsbad

95138

Camino Ear Nose & Throat Clinic, San Jose

95661

Sacramento ENT, Roseville

06106

Connecticut Children's Medical Center, Hartford

06510

Yale School of Medicine, Section of Otolaryngology, New Haven

V6H 3N1

British Columbia Children's Hospital, Vancouver

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Tusker Medical

INDUSTRY

NCT03323736 - In-Office Tympanostomy Tube Placement in Children (OTTER) | Biotech Hunter | Biotech Hunter