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临床试验/NCT07775495
NCT07775495尚未招募不适用

Observational Study of Decentralized Urine Optical Interaction Patterns Associated With Environmental Microplastic and Nanoplastic Exposure

Ecotera Health LLC51 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15
试验地点
51
主要终点
Percentage of Scheduled Study Visits Completed by Participants

研究概览

简要总结

The goal of this observational study is to evaluate the feasibility and usability of at-home urine sample collection, preparation, and smartphone imaging using the EcoExposure™ platform in adults. The main questions it aims to answer are:

Can participants successfully collect, prepare, and photograph urine samples at home and upload the images using a smartphone app? How consistent is image quality and participant adherence across repeated sampling over approximately 12 weeks? What is the short-term day-to-day variability in optical signals during an intensive daily sampling period?

Participants will:

Complete electronic consent and a brief intake questionnaire Collect and prepare urine samples at home at scheduled timepoints Capture guided smartphone photographs of the prepared samples Upload the images and provide brief feedback through the TrialKit app Optionally add a small reference solution (spike sample) to one sample for technical evaluation only

The study is fully remote and lasts approximately 12 weeks. It is intended for product development and workflow validation purposes only and does not involve any diagnostic or clinical decision-making.

详细描述

This is a decentralized, observational, product-development study evaluating the EcoExposure™ platform for at-home urine sample collection, preparation, and smartphone-based imaging. The study is non-clinical and is not intended to diagnose, treat, or provide health risk assessments.

Approximately [X] adult participants will be enrolled for a duration of about 12 weeks. All activities are performed remotely using the participant's own smartphone and the TrialKit platform for electronic consent, guided workflows, image capture, and data submission.

Participants will collect and prepare fresh urine samples at home according to provided instructions, capture guided photographs of the prepared samples, and upload the images along with brief feedback. Sampling occurs at the following timepoints: Day 0 (baseline), daily from Day 7 through Day 14 (intensive short-term variability assessment), and then at Days 21, 28, 42, 56, 70, and 84.

An optional technical reference ("spike") sample may be offered. Participants who choose this option will add a small volume of a known-concentration reference solution to one of their prepared urine samples before imaging. This step is solely for internal assay and workflow evaluation and will not be used for any clinical interpretation.

Primary focus areas include participant adherence and completion rates, image quality and usability, workflow feasibility in a fully remote setting, and qualitative assessment of optical signal consistency over time (including comparison of native versus optionally spiked samples for internal development purposes only).

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

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

入选标准

  • Adults aged 18 years or older
  • Able to provide electronic informed consent
  • Willing and able to collect and prepare urine samples at home according to study instructions
  • Own a smartphone capable of running the TrialKit application and capturing photographs
  • Willing to complete the required study visits over approximately 12 weeks

排除标准

  • Unable or unwilling to perform the study procedures (urine collection, sample preparation, smartphone imaging, and data upload)
  • Any condition or circumstance that, in the judgment of the investigator, would prevent the participant from successfully completing the study protocol

研究组 & 干预措施

EcoExposure Urine Observational Cohort

All participants complete the same decentralized urine collection, preparation, and smartphone imaging workflow at scheduled timepoints over approximately 12 weeks. An optional technical reference (spike) sample may be offered; participants who choose this option add a small volume of a known-concentration reference solution to one prepared urine sample before imaging. This optional step is for internal assay and workflow evaluation only and does not create a separate analysis group or change the primary study procedures.

结局指标

主要结局

Percentage of Scheduled Study Visits Completed by Participants

时间窗: From Day 0 to Day 84

Percentage of all scheduled study visits completed by each participant during the 84-day study, including the daily sampling period on Days 7-14.

Percentage of Completed Study Visits With All Required Study Data

时间窗: Throughout the study (Day 0 to Day 84)

Percentage of completed study visits containing all required study data, including recording required urine sample information and uploading images to the secure study app. This measure will be used to assess the feasibility of the decentralized at-home study workflow.

次要结局

  • Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria(Across all scheduled timepoints (Day 0 to Day 84))
  • Participant Rating of Ease of Using the At-Home Urine Collection and Imaging Workflow(Across all scheduled timepoints (Day 0 to Day 84))
  • Change in EcoExposure™ Microplastic and Nanoplastic Optical Measurements During Daily Urine Sampling(Day 7-14)

研究者

发起方
Ecotera Health LLC
申办方类型
企业
责任方
申办方

研究点 (51)

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标识符

NCT 编号
NCT07775495
其他研究编号
ecotera-1001, ecotera-1001

日期

首次提交
(上个月)
首次发布
(上个月)
主要完成日期
(3个月后)
研究完成日期
(4个月后)
最近核实
(2个月前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
UNDECIDED
是否有结果
否

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