Study of the Hummingbird TTS™ Tympanostomy Tube System
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 5 |
| Updated: | 10/20/2018 |
| Start Date: | January 29, 2016 |
| End Date: | November 2019 |
| Contact: | Sarah Hase, BA |
| Email: | clinical@preceptismedical.com |
| Phone: | 763-710-4518 |
Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System
The objective of this study is 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 moderate sedation and local anesthetic.
and performance of the H-TTS for the placement of ventilation tubes in pediatric patients
undergoing a tympanostomy procedure under moderate sedation and local anesthetic.
The study will be a multi-site, prospective, treatment-only post-market study of the H-TTS.
The study will be performed in a commercial environment. Patients will already have a
scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.
A minimum of one hundred-sixty-seven (167) subjects will be included in the study at 5 sites.
The study will be performed in a commercial environment. Patients will already have a
scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.
A minimum of one hundred-sixty-seven (167) subjects will be included in the study at 5 sites.
Inclusion Criteria:
- Age 6 months through 5 years of age
- Candidates for ventilation tube placement
- H-TTS used under moderate sedation and local anesthetic
We found this trial at
4
sites
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Beverly Hills, California 90211
Principal Investigator: Gene Liu, MD
Phone: 310-385-2974
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Saint Cloud, Minnesota 56303
Principal Investigator: Theodore Truitt, MD
Phone: 320-204-5887
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