Healthy Adult ParticipantsOMNUNCT07775495

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

An observational study of Healthy Adult Participants, run by Ecotera Health LLC at 51 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Adult Participants
How many people: 15 participants
Where: 51 sitesUnited States
Study dates: 21 Oct 2026to 31 Jan 2027
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: 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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

51 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cameron Y. Research Coordinator, M. Phil contact

+15132787420

hello@ecoterahealth.com

City, postcode or hospital

Sites recruiting now only

51 sites in 1 country

United States51 sites, 51 recruiting

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

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions: Healthy Adult Participants
Keywords: environmental, environmental health, environmental exposure, microplastics, nanoplastics, urine, smartphone, feasibility, usability, at-home, decentratlized, observational, optical analysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07775495
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Scheduled Study Visits Completed by Participants
Percentage of all scheduled study visits completed by each participant during the 84-day study, including the daily sampling period on Days 7-14.
Measured: From Day 0 to Day 84
Percentage of Completed Study Visits With All Required Study Data
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.
Measured: Throughout the study (Day 0 to Day 84)

Secondary outcomes (3)

Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria
Percentage of uploaded urine sample images that meet predefined image quality criteria for analysis using the EcoExposure™ image-analysis method.
Measured: Across all scheduled timepoints (Day 0 to Day 84)
Participant Rating of Ease of Using the At-Home Urine Collection and Imaging Workflow
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.
Measured: Across all scheduled timepoints (Day 0 to Day 84)
Change in EcoExposure™ Microplastic and Nanoplastic Optical Measurements During Daily Urine Sampling
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).
Measured: Day 7-14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202631 Jan 2027

First posted20 Aug 2026
Study start21 Oct 2026 (estimated)
Primary completion31 Dec 2026 (estimated)
Study completion31 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07775495
Sponsor's protocol ID: ecotera-1001
Other IDs: ecotera-1001
Acronym: OMNU
Status last verified: Sep 2026
First submitted: 2 Aug 2026
Last updated: 1 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Cameron Y. Research Coordinator, M. Phil

+15132787420

hello@ecoterahealth.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Healthy Adult Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study of Decentralized Urine Optical Interaction Patterns Associated With Environmental Microplastic and Nanoplastic Exposure
ClinicalTrials.gov ID: NCT07775495
Acronym / sponsor ID: OMNU / ecotera-1001
Conditions: Healthy Adult Participants
Keywords: environmental, environmental health, environmental exposure, microplastics, nanoplastics, urine, smartphone, feasibility
Study type: Observational
Recruitment status: Recruiting
Enrolment: 15 participants (estimated)
Lead sponsor: Ecotera Health LLCIndustry (pharma, biotech, devices)
Study start: 21 Oct 2026 (estimated)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Jan 2027 (estimated)
First posted: 20 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants will:

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Scheduled Study Visits Completed by Participants
Time frame: 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
Time frame: 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.

3 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Individual participant dataSharing planned: Undecided

Related trials for Healthy Adult Participants

RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
Active, not recruitingPhase 1
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
Healthy Volunteers, Hyperuricemia
Not yet recruiting
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
Postprandial Glucose, GI Tolerance
Enrolling by invitationEarly Phase 1
Acute Effects of a Single Dose of Ayahuasca on Cerebral Metabolism in Healthy Volunteers: a PET Study
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Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Cameron Y. Research Coordinator, M. Phil contact

+15132787420

hello@ecoterahealth.com

Melinda B. Chu, M.D. M.B.A. study director

Ecotera Health LLC

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Adult Participants, run by Ecotera Health LLC at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cameron Y. Research Coordinator, M. Phil (+15132787420, hello@ecoterahealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Scheduled Study Visits Completed by Participants (time frame: From Day 0 to Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07775495.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.