Status:
UNKNOWN
Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study.
Lead Sponsor:
Northwell Health
Conditions:
Ear Barotrauma
Middle Ear Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistica...
Detailed Description
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistica...
Eligibility Criteria
Inclusion
- \- Any patient meeting the proper diagnosis and indications to be treated with hyperbaric oxygen.
Exclusion
- Any patient with absolute contraindications to hyperbaric oxygen treatment
- Patients with chronic bilateral perforation of the tympanic membrane or;
- A history of prior surgical placement of myringotomy tubes.
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04804098
Start Date
September 20 2021
End Date
December 1 2024
Last Update
October 19 2023
Active Locations (1)
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1
Phelps Hospital Northwell Health
Sleepy Hollow, New York, United States, 10591