CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

Laryngopharyngeal Reflux Clinical Trial

Official title:

CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03214835
• Other study ID #: CDx Laryngeal and LPR Study
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 2019

Study information

• Verified date: July 2020
• Source: CDx Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or over

• patients suspected to suffer from LPR

• Patients with laryngeal/hypopharyngeal lesions.

Exclusion Criteria:

• Patient refusal

• Patients with anatomical variants which precludes biopsy taking.

• Patients with allergy to lidocain-based local anesthesia agents.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Laryngeal Disease
• Laryngeal Diseases
• Laryngeal Tumor
• Laryngopharyngeal Reflux

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
CDx Diagnostics	Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of EndoCDx brush	Efficacy of EndoCDx brush biopsy as a diagnostic tool for laryngeal lesions compared to cup forceps biopsy and a diagnostic tool for LPR compared to double probe PH monitoring	3 months
Secondary	Assessment of pain	Assessment of pain during EndoCDx brush biopsy under local anesthesia by Visual Analog Score for pain	6 months