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

2026年8月16日 更新者：Ecotera Health LLC

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.

研究概览

地位

尚未招聘

条件

详细说明

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).

No diagnostic claims, clinical endpoints, or treatment recommendations are involved. Results will support product development, workflow optimization, and assay calibration.

研究类型

观察性的

注册 (估计的)

15

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35005
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
        • 首席研究员：
          • Mona Ascha, M.D.
    • Alaska
      • Anchorage、Alaska、美国、99501
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
        • 首席研究员：
          • Mona Ascha, M.D.
    • Arizona
      • Phoenix、Arizona、美国、85001
        • Decentralized / At-Home Participation (U.S.)
    • Arkansas
      • Little Rock、Arkansas、美国、72295
        • Decentralized / At-Home Participation (U.S.)
        • 首席研究员：
          • Mona Ascha, M.D.
    • California
      • San Francisco、California、美国、94102
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Colorado
      • Denver、Colorado、美国、80014
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Connecticut
      • Hartford、Connecticut、美国、06105
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
        • 首席研究员：
          • Mona Ascha, M.D.
    • Delaware
      • Dover、Delaware、美国、19901
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20001
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Florida
      • Miami、Florida、美国、33101
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Georgia
      • Atlanta、Georgia、美国、30303
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Hawaii
      • Honolulu、Hawaii、美国、96801
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Idaho
      • Boise、Idaho、美国、83702
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Illinois
      • Chicago、Illinois、美国、60601
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Indiana
      • Indianapolis、Indiana、美国、46201
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Iowa
      • Des Moines、Iowa、美国、50301
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Kansas
      • Kansas City、Kansas、美国、66101
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Kentucky
      • Louisville、Kentucky、美国、40201
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Maine
      • Augusta、Maine、美国、04330
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Maryland
      • Baltimore、Maryland、美国、21201
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Massachusetts
      • Boston、Massachusetts、美国、02108
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Michigan
      • Detroit、Michigan、美国、48201
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Minnesota
      • Minneapolis、Minnesota、美国、55401
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Mississippi
      • Jackson、Mississippi、美国、39201
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Missouri
      • St Louis、Missouri、美国、63117
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Montana
      • Billings、Montana、美国、59101
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Nebraska
      • Omaha、Nebraska、美国、68102
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Nevada
      • Las Vegas、Nevada、美国、89101
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • New Hampshire
      • Manchester、New Hampshire、美国、03101
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • New Jersey
      • Newark、New Jersey、美国、07102
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • New Mexico
      • Albuquerque、New Mexico、美国、87101
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • New York
      • New York、New York、美国、10003
        • Decentralized / At-Home Participation (U.S.)
        • 首席研究员：
          • Mona Ascha, M.D.
        • 接触：
    • North Carolina
      • Charlotte、North Carolina、美国、28202
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • North Dakota
      • Fargo、North Dakota、美国、58102
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Ohio
      • Cincinnati、Ohio、美国、45242
        • Decentralized / At-Home Participation (U.S.)
        • 首席研究员：
          • Mona Ascha, M.D.
        • 接触：
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73102
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Oregon
      • Portland、Oregon、美国、97201
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19102
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • South Carolina
      • Charleston、South Carolina、美国、29401
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • South Dakota
      • Sioux Falls、South Dakota、美国、57104
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Tennessee
      • Nashville、Tennessee、美国、37201
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Texas
      • Houston、Texas、美国、77002
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Utah
      • Salt Lake City、Utah、美国、84101
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Vermont
      • Burlington、Vermont、美国、05401
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Virginia
      • Virginia Beach、Virginia、美国、23451
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Washington
      • Seattle、Washington、美国、98101
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • West Virginia
      • Charleston、West Virginia、美国、25301
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53202
        • Decentralized / At-Home Participation (U.S.)
        • 接触：
    • Wyoming
      • Cheyenne、Wyoming、美国、82001
        • Decentralized / At-Home Participation (U.S.)
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Adults aged 18 years and older who are willing and able to collect and prepare urine samples at home, capture smartphone photographs of the prepared samples, and upload the images through a mobile application. Participants may have common medical conditions; the ability to complete the study procedures is the primary requirement.

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Scheduled Study Visits Completed by Participants
大体时间：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.
From Day 0 to Day 84
Percentage of Completed Study Visits With All Required Study Data
大体时间：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.
Throughout the study (Day 0 to Day 84)

次要结果测量

结果测量
措施说明
大体时间
Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria
大体时间：Across all scheduled timepoints (Day 0 to Day 84)
Percentage of uploaded urine sample images that meet predefined image quality criteria for analysis using the EcoExposure™ image-analysis method.
Across all scheduled timepoints (Day 0 to Day 84)
Participant Rating of Ease of Using the At-Home Urine Collection and Imaging Workflow
大体时间：Across all scheduled timepoints (Day 0 to Day 84)
Participants will rate the ease of using the at-home urine collection and imaging workflow on a 5-point rating scale from 1 to 5, with higher scores indicating greater ease of use.
Across all scheduled timepoints (Day 0 to Day 84)
Change in EcoExposure™ Microplastic and Nanoplastic Optical Measurements During Daily Urine Sampling
大体时间：Day 7-14
Urine samples will be measured using the EcoExposure™ optical assay and an image-analysis method that analyzes photographs of the samples. The study will compare how microplastic- and nanoplastic-related optical measurements change within the same participant during daily urine sampling (Days 7-14).
Day 7-14

其他结果措施

结果测量
措施说明
大体时间
Difference in EcoExposure™ Optical Measurements Between Native and Microplastic/Nanoplastic-Spiked Urine Samples
大体时间：Day 0 through Day 84, at the study visit when optional spiked-sample testing is performed
When the optional spiked sample (urine sample where additional microplastic solution is added to the urine sample using an eyedropper) is performed, the participant's native urine sample and the spiked urine sample will be measured using the EcoExposure™ optical assay and image-analysis method. Optical measurements from the native and spiked samples will be compared to evaluate differences in assay response at different microplastic and nanoplastic levels.
Day 0 through Day 84, at the study visit when optional spiked-sample testing is performed

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ecotera Health LLC

调查人员

  • 研究主任：Melinda B. Chu, M.D. M.B.A.、Ecotera Health LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月21日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年8月2日

首先提交符合 QC 标准的

2026年8月16日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月16日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • ecotera-1001 (其他标识符：ecotera health)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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