Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-26 @ 1:09 AM
Study NCT ID:
NCT05497934
Status:
WITHDRAWN
Last Update Posted:
2024-08-21
First Post:
2022-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear
Sponsor:
Nova Scotia Health Authority
Organization:
Study Overview
Official Title:
The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No response from initial letter or expiry email- closed by REB office
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the improvement in middle ear optical coherence tomography imaging from the topical application of glycerol to the tympanic membrane in normal, opaque and post-operative ears
Detailed Description:
This study will explore whether the utility of Optical Coherence Tomography (OCT) in otology patients can be enhanced through the application of topical glycerol as an optical clearing agent in patients with normal, opaque and post operative tympanic membranes. In each group of subjects, a comparison will be made between OCT images obtained before and after the topical application of glycerol to the tympanic membrane and following washout with saline. Images will also be assessed for their diagnostic utility as determined by the visibility of key structures and the change in middle ear mobility caused by glycerol absorption in the tympanic membrane.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: