跳至主要内容
临床试验/NCT03810833
NCT03810833已完成不适用

A Study of Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System

MediBeacon1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年9月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Mean Background Fluorescence

研究概览

简要总结

This study is designed to evaluate background fluorescence of participants of different ages, gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be evaluated.

详细描述

The MediBeacon Transdermal GFR Measurement System investigational is intended to measure the Glomerular Filtration Rate (GFR) in patients with normal or impaired renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent (MB-102) over time. The device utilized in this study is the Brilliance device. Approximately 1 male and 1 female from each age cohort (18-50 years; 51+ years) and clustered Fitzpatrick Skin Scale groups (I-II [Light, pale white; white, fair]; III-IV [Medium, white to olive; olive, moderate brown]; and V-VI [Brown, dark brown; black, very dark brown to black]) will be recruited, for a total of 12 participants. Participants will have Brilliance device sensors placed on two locations on their skin, which will remain for 48 hours. The sensor location will be prepared through shaving and cleaning (as applicable), placed on the skin via standard single-use adhesive pads, and baseline measurements collected. Participants may undergo activities of daily living while measurements are being collected. Light pressure and other minor perturbations may be applied to the sensors to evaluate the effect on background fluorescence. Adverse events associated with sensor placement (such as skin irritations) will be recorded.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy male and female adults age 18 and older
  • •2 age cohorts to be recruited: 18 - 50 years of age and 51+ years or older
  • •Skin color groups to be recruited in accordance with the Fitzpatrick Skin Scale (I - VI)
  • •Participants willing to sign the Institutional Review Board (IRB) approved informed consent form prior to the initiation of any study specific procedures.

排除标准

  • •History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
  • •Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
  • •Significant scarring, tattoos or alterations in pigmentation on the standardized sensor locations that would alter sensor readings versus other areas of the skin

研究组 & 干预措施

Participants with Brilliance sensor placement

Experimental

Brilliance device sensors placed on the left and right pectoralis major, remaining for 48 hours

干预措施: Brilliance device sensor (Device)

结局指标

主要结局

Mean Background Fluorescence

时间窗: From the time of sensor placement to 48 hours after placement

Two separate Brilliance device sensors will be attached via standard adhesive pads to the left and right pectoralis major on each participant. Fluorescence measurements will be collected directly by the MediBeacon Transdermal GFR Measurement System Brilliance device, and will be continuously collected throughout the 48 hour study.

次要结局

未报告次要终点

研究者

发起方
MediBeacon
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验