Laryngeal DiseaseNCT03214835
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions
A study testing Endo CDx Brush biopsy in people with Laryngeal Disease and Laryngeal Tumor, run by CDx Diagnostics.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Disease, Laryngeal Tumor, Laryngopharyngeal Reflux
- What is being tested?
- Endo CDx Brush biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or over
- patients suspected to suffer from LPR
- Patients with laryngeal/hypopharyngeal lesions.
Who cannot join
- Patient refusal
- Patients with anatomical variants which precludes biopsy taking.
- Patients with allergy to lidocain-based local anesthesia agents.
About this study
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.
Read the 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
- Being tested
- Endo CDx Brush biopsy
- Keywords
- Larynx, reflux, LPR, tumor, lesion
- Medical subject headings
- Laryngeal Diseases, Laryngopharyngeal Reflux, Gastroesophageal Reflux, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Brush biopsy for laryngeal lesion | Experimental | Brush biopsy of the larynx - in addition to the standard biopsy Receives: 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) Receives: Device: Endo CDx Brush biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
Assessment of pain
Assessment of pain during EndoCDx brush biopsy under local anesthesia by Visual Analog Score for pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Feb 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Study halted prematurely, prior to enrollment of first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CDx Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Sponsor
- Investigators
- Jacob Cohen, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214835
- Sponsor's protocol ID
- CDx Laryngeal and LPR Study
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2017
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions
- ClinicalTrials.gov ID
- NCT03214835
- Acronym / sponsor ID
- CDx Laryngeal and LPR Study
- Conditions
- Laryngeal Disease, Laryngeal Tumor, Laryngopharyngeal Reflux
- Keywords
- Larynx, reflux, LPR, tumor, lesion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CDx DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brush biopsy for laryngeal lesion | Experimental | Device: Endo CDx Brush biopsyBrush biopsy of the larynx - in addition to the standard biopsy |
| Brush biopsy for LPR | Experimental | Device: Endo CDx Brush biopsyBrush biopsy of the larynx at the post cricoid region - in addition to the standard examination for LPR (PH monitoring double probe) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or over
- patients suspected to suffer from LPR
- Patients with laryngeal/hypopharyngeal lesions.
Key exclusion criteria (3 listed)
- Patient refusal
- Patients with anatomical variants which precludes biopsy taking.
- Patients with allergy to lidocain-based local anesthesia agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endo CDx Brush biopsyIn 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. | Device | Brush biopsy for LPR, Brush biopsy for laryngeal lesion |
Primary outcome
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
1 secondary outcome
Assessment of pain
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Cohen, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A study testing Endo CDx Brush biopsy in people with Laryngeal Disease and Laryngeal Tumor, run by CDx Diagnostics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of EndoCDx brush (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.