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CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03214835
Enrollment
0
Registered
2017-07-12
Start date
2018-02-01
Completion date
2019-12-31
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Disease, Laryngeal Tumor, Laryngopharyngeal Reflux

Keywords

Larynx, reflux, LPR, tumor, lesion

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.

Interventions

DEVICEEndo 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.

Sponsors

Rambam Health Care Campus
CollaboratorOTHER
CDx Diagnostics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of EndoCDx brush3 monthsEfficacy 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

Secondary

MeasureTime frameDescription
Assessment of pain6 monthsAssessment of pain during EndoCDx brush biopsy under local anesthesia by Visual Analog Score for pain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026