NCT03214835

CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CDx Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laryngeal Disease
• Laryngeal Tumor
• Laryngopharyngeal Reflux

Interventions

Type	Name	Description
DEVICE	Endo CDx Brush biopsy	In patients with laryngeal lesion the brush biopsy will be taken with the standard cup biopsy - either in the clinic or in the OR. In LPR patients brush biopsy will be taken in the clinic.

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-08-01
• Completion: 2019-12-01
• First posted: 2017-07-12
• Last updated: 2020-07-20