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

16 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

15

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Cameron Y. Research Coordinator, M. Phil
  • Número de teléfono: +15132787420
  • Correo electrónico: hello@ecoterahealth.com

Ubicaciones de estudio

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35005
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
        • Investigador principal:
          • Mona Ascha, M.D.
    • Alaska
      • Anchorage, Alaska, Estados Unidos, 99501
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
        • Investigador principal:
          • Mona Ascha, M.D.
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85001
        • Decentralized / At-Home Participation (U.S.)
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72295
        • Decentralized / At-Home Participation (U.S.)
        • Investigador principal:
          • Mona Ascha, M.D.
    • California
      • San Francisco, California, Estados Unidos, 94102
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Colorado
      • Denver, Colorado, Estados Unidos, 80014
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Connecticut
      • Hartford, Connecticut, Estados Unidos, 06105
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
        • Investigador principal:
          • Mona Ascha, M.D.
    • Delaware
      • Dover, Delaware, Estados Unidos, 19901
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20001
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Florida
      • Miami, Florida, Estados Unidos, 33101
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30303
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96801
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Idaho
      • Boise, Idaho, Estados Unidos, 83702
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60601
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46201
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Iowa
      • Des Moines, Iowa, Estados Unidos, 50301
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66101
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40201
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Maine
      • Augusta, Maine, Estados Unidos, 04330
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02108
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55401
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Mississippi
      • Jackson, Mississippi, Estados Unidos, 39201
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63117
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Montana
      • Billings, Montana, Estados Unidos, 59101
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68102
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89101
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • New Hampshire
      • Manchester, New Hampshire, Estados Unidos, 03101
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • New Jersey
      • Newark, New Jersey, Estados Unidos, 07102
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87101
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • New York
      • New York, New York, Estados Unidos, 10003
        • Decentralized / At-Home Participation (U.S.)
        • Investigador principal:
          • Mona Ascha, M.D.
        • Contacto:
          • Cameron Y. Research Coordinator, M.Phil
          • Número de teléfono: 15132787420
          • Correo electrónico: hello@ecoterahealth.com
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28202
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • North Dakota
      • Fargo, North Dakota, Estados Unidos, 58102
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45242
        • Decentralized / At-Home Participation (U.S.)
        • Investigador principal:
          • Mona Ascha, M.D.
        • Contacto:
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73102
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Oregon
      • Portland, Oregon, Estados Unidos, 97201
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19102
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29401
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • South Dakota
      • Sioux Falls, South Dakota, Estados Unidos, 57104
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37201
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Texas
      • Houston, Texas, Estados Unidos, 77002
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84101
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Vermont
      • Burlington, Vermont, Estados Unidos, 05401
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Virginia
      • Virginia Beach, Virginia, Estados Unidos, 23451
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Washington
      • Seattle, Washington, Estados Unidos, 98101
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • West Virginia
      • Charleston, West Virginia, Estados Unidos, 25301
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53202
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:
    • Wyoming
      • Cheyenne, Wyoming, Estados Unidos, 82001
        • Decentralized / At-Home Participation (U.S.)
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Scheduled Study Visits Completed by Participants
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in EcoExposure™ Optical Measurements Between Native and Microplastic/Nanoplastic-Spiked Urine Samples
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ecotera Health LLC

Investigadores

  • Director de estudio: Melinda B. Chu, M.D. M.B.A., Ecotera Health LLC

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

21 de agosto de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

31 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de agosto de 2026

Publicado por primera vez (Actual)

20 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • ecotera-1001 (Otro identificador: ecotera health)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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