A Prospective, Single-Arm, Multicenter Study to Evaluate Effectiveness and Safety of Tympanostomy Tube Placement Using the TULA Iontophoresis and Tube Delivery Systems for Children in an Office Setting
| Sponsor: |
Tusker Medical |
| Enrolling: |
Male and Female Patients |
| IRB Number: |
AAAR4413 |
| Contact: |
Jessica Campbell: 212-305-2298 / jc4353@cumc.columbia.edu |
The objective of the study is to evaluate the safety and effectiveness of the TULA System for the placement of tympanostomy tubes (ear tubes) under local anesthesia in an office/clinic setting.
This study is closed
Investigator
Eli Grunstein, MD
| Is your child male or female at least 6 months old through 12 years old? |
Yes |
No |
| Does your child have the indication for tympanostomy tube insertion? |
Yes |
No |