Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-25 @ 4:45 PM
Study NCT ID:
NCT05204303
Status:
UNKNOWN
Last Update Posted:
2022-09-02
First Post:
2022-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LPR Fluorescence Pilot
Sponsor:
The Functional Gut Clinic
Organization:
Study Overview
Official Title:
Analysis of Mouthwash Samples From Laryngopharyngeal Reflux (LPR) Patients and Healthy Volunteers Using Barrel-array Diagnostics
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (LPR) and healthy volunteers.
Detailed Description:
The investigators aim to test if the biosensing platform Pandra, developed by Rosa Biotech, may be suitable to distinguish patients with LPR symptoms, both with and without objective evidence of gastroesophageal reflux disease (GORD), vs healthy volunteers due to their expected inflammation and cell changes in the laryngo-pharyngeal region. The investigators intend to analyse 20 samples of mouthwash solutions from each of the following groups:
A. Patients with symptoms of LPR and objective evidence of GORD B. Patients with symptoms of LPR and no objective evidence of GORD C. Healthy volunteer group
A. Patients with symptoms of LPR and objective evidence of GORD B. Patients with symptoms of LPR and no objective evidence of GORD C. Healthy volunteer group
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?:
None
Is an FDA AA801 Violation?: