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临床试验/NCT03214835
NCT03214835撤回不适用

CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

CDx Diagnostics0 个研究点开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Efficacy of EndoCDx brush

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Efficacy of EndoCDx brush

时间窗: 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

次要结局

  • Assessment of pain(6 months)

研究者

发起方
CDx Diagnostics
申办方类型
Industry
责任方
Sponsor

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