Evaluation of the Clinical Utility of Electrical Impedance Spectroscopy in Normal Clinical Practice at Hospital Setting
试验速览
- 阶段
- 不适用
- 发起方
- SciBase AB
- 入组人数
- 180
- 主要终点
- Number needed to biopsy
研究概览
简要总结
The purpose of this clinical study is to evaluate the clinical utility of the Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human & Machine) based on Nevisense measurement at time of biopsy decision.
详细描述
This is a multi-center, prospective, blinded clinical study designed to evaluate clinical utility of Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human & Machine) based on Nevisense measurement after biopsy decision. The study enrollment will continue until minimum of 180 subjects are enrolled in the study. Up to 3 US university/hospital investigational sites will participate in this study. Biopsying clinician or the investigators from the clinical practices of physicians participating in the study will perform the patient and lesion assessment for biopsy as standard of care at the clinic.
Study subjects will be recruited from the clinical practices of physicians participating as investigators in this study. Biopsying clinicians provide their assessment to whether s/he would have sent the lesion(s) for biopsy had s/he known the EIS information beforehand . Thereafter an evaluation of the suspicious lesion with the Nevisense will be performed followed by a biopsy of the lesion. The biopsied lesion will be subjected to histological analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The lesion(s) meet criteria for Nevisense evaluation.
- •Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi) -Thus, necessitating a biopsy.
- •Lesions within Nevisense indication for use: Nevisense is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. Nevisense is indicated only for use on:
- •primary skin lesions with a diameter between 2 mm and 20 mm;
- •lesions that are accessible by the Nevisense probe;
- •lesions where the skin is intact (i.e. non-ulcerated or non-bleeding lesions);
- •lesions that do not contain a scar or fibrosis consistent with previous trauma;
- •lesions not located in areas of psoriasis, eczema, acute sunburn or similar skin conditions;
- •lesions not in hair-covered areas;
- •lesions which do not contain foreign matter;
- •lesions not on special anatomic sites (i.e. not for use on acral skin, genitalia, eyes, mucosal areas).
排除标准
- •Subjects who fail to provide informed consent
- •Study subjects with underlying medical disease which may alter ability to diagnose clinically or inhibit Nevisense from collecting data
结局指标
主要结局
Number needed to biopsy
时间窗: 1 day
The primary study outcome is the number needed to biopsy to detect a single melanoma case.
次要结局
未报告次要终点