NCT03214835

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

July 10, 2017

Last Update Submit

July 16, 2020

Conditions

Laryngeal DiseaseLaryngeal TumorLaryngopharyngeal Reflux

Keywords

LarynxrefluxLPRtumorlesion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessment of pain

    6 months

Study Arms (2)

Brush biopsy for laryngeal lesion

EXPERIMENTAL

Brush biopsy of the larynx - in addition to the standard biopsy

Device: Endo CDx Brush biopsy

Brush biopsy for LPR

EXPERIMENTAL

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

Interventions

Endo CDx Brush biopsyDEVICE

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.

Brush biopsy for LPRBrush biopsy for laryngeal lesion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or over
  • patients suspected to suffer from LPR
  • Patients with laryngeal/hypopharyngeal lesions.

You may not qualify if:

  • Patient refusal
  • Patients with anatomical variants which precludes biopsy taking.
  • Patients with allergy to lidocain-based local anesthesia agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Laryngeal DiseasesLaryngopharyngeal RefluxGastroesophageal RefluxNeoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Jacob Cohen, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 12, 2017

Study Start

February 1, 2018

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

July 20, 2020

Record last verified: 2020-07