Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-04 @ 1:33 AM
Study NCT ID:
NCT03214835
Status:
WITHDRAWN
Last Update Posted:
2020-07-20
First Post:
2017-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions
Sponsor:
CDx Diagnostics
Organization:
Study Overview
Official Title:
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions
Status:
WITHDRAWN
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted prematurely, prior to enrollment of first participant.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will take place at Rambam medical center, department of Otolaryngology Head and Neck Surgery, for two years. Patients suspected of LPR or laryngeal l tumor and are candidate for laryngeal or hypopharyngeal biopsies will be recruited.
Detailed Description:
First- all patients visiting our clinic with laryngeal complaints suspicious for either LPR or laryngeal tumor will fill the RSI questionnaire. Then fiberoptic examination will be performed by a laryngologist that will complete the RFS score.
Patients with suspicious lesions will be referred for TFL standard biopsy and CDx brush biopsy in order to determine whether the lesions are malignant or benign. The pathologic diagnosis of invasive carcinoma from a TFL biopsy is considered equivalent to the pathology results from a direct laryngoscopy biopsy. All patients with benign pathology or carcinoma in-situ (CIS) on TFL biopsy will be referred for subsequent direct laryngoscopy (DL) for definitive diagnosis. At the time of the DL biopsy will include also another CDx brush smear. Patients with benign-appearing lesions will be taken for lesion removal and biopsy.Before removal of the lesion a CDx brush smear will be collected.
All the participants suspected of LPR will have: PHmetry with Manometry andCDx brush biopsy.All relevant demographic and clinical data will be retrieved for analysis.
CDx biopsies will be an addition to the routine management of the patients in the diagnosis and follow-up of laryngeal lesions and LPR and will not replace the standard regimen.
Patients with suspicious lesions will be referred for TFL standard biopsy and CDx brush biopsy in order to determine whether the lesions are malignant or benign. The pathologic diagnosis of invasive carcinoma from a TFL biopsy is considered equivalent to the pathology results from a direct laryngoscopy biopsy. All patients with benign pathology or carcinoma in-situ (CIS) on TFL biopsy will be referred for subsequent direct laryngoscopy (DL) for definitive diagnosis. At the time of the DL biopsy will include also another CDx brush smear. Patients with benign-appearing lesions will be taken for lesion removal and biopsy.Before removal of the lesion a CDx brush smear will be collected.
All the participants suspected of LPR will have: PHmetry with Manometry andCDx brush biopsy.All relevant demographic and clinical data will be retrieved for analysis.
CDx biopsies will be an addition to the routine management of the patients in the diagnosis and follow-up of laryngeal lesions and LPR and will not replace the standard regimen.
Study Oversight
Has Oversight DMC:
True
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?: