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Trial record 6 of 98 for:    Recruiting, Not yet recruiting, Available Studies | "Laryngeal Diseases"

CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

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ClinicalTrials.gov Identifier: NCT03214835
Recruitment Status : Not yet recruiting
First Posted : July 12, 2017
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by (Responsible Party):
CDx Diagnostics

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.

Condition or disease Intervention/treatment Phase
Laryngeal Disease Laryngeal Tumor Laryngopharyngeal Reflux Device: Endo CDx Brush biopsy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy GERD

Arm Intervention/treatment
Experimental: Brush biopsy for laryngeal lesion
Brush biopsy of the larynx - in addition to the standard biopsy
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.

Experimental: Brush biopsy for LPR
Brush biopsy of the larynx at the post cricoid region - in addition to the standard examination for LPR (PH monitoring double probe)
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.




Primary Outcome Measures :
  1. Efficacy of EndoCDx brush [ Time Frame: 3 months ]
    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


Secondary Outcome Measures :
  1. Assessment of pain [ Time Frame: 6 months ]
    Assessment of pain during EndoCDx brush biopsy under local anesthesia by Visual Analog Score for pain



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214835


Contacts
Contact: Limor Benyamini, MD 1700505150 info@rambam.health.gov.il
Contact: Jacob Cohen, MD 047772480

Sponsors and Collaborators
CDx Diagnostics
Rambam Health Care Campus
Investigators
Principal Investigator: Jacob Cohen, MD Rambam Health Care Campus

Responsible Party: CDx Diagnostics
ClinicalTrials.gov Identifier: NCT03214835     History of Changes
Other Study ID Numbers: CDx Laryngeal and LPR Study
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CDx Diagnostics:
Larynx
reflux
LPR
tumor
lesion

Additional relevant MeSH terms:
Laryngeal Diseases
Gastroesophageal Reflux
Laryngopharyngeal Reflux
Laryngeal Neoplasms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms