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Experimental device trial launches without FDA approval

NCT ID NCT05897164

Knowledge-focused Sponsor: Evidence-Based Practice Institute, Seattle, WA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests a device that has not been approved by the U.S. FDA. The purpose is to collect information on how the device works and its safety. Participants will help researchers understand if the device could be useful in the future.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: Youth: * Resides in United States * 13-17 years of age * Fluent in English * Possesses and is the primary user of an Android or iPhone-based smartphone with a data plan that they use on a daily basis * Currently residing in the same household with the linked caregiver/legal guardian participant at least five days a week * Meets criteria for mild-moderate or severe SA (for any drug or alcohol) on the Screening to Brief Intervention (S2BI), indicated by answering that they have used any substance at least once per month within the past 90 days. * Possesses and is the primary user of an Android or iPhone-based smartphone with a data plan Caregivers: * Resides in United States * 18 years or older * Fluent in English * Owns and is the primary user of an Android or iPhone-based smartphone with a data plan that they use on a daily basis * Able and willing to receive and send several (1-3 times/week) text messages from study staff during study participation * Is the primary caregiver of a youth aged 13-17 years who lives in the caregiver's home at least five days a week * Caregiver indicates a substance concern for the target youth, defined as either a+b OR c: 1. uses alcohol, marijuana, and/or another substance, AND 2. expresses that they are concerned (a score of 3 or higher) about that use on a 5-pt Likert scale (3 = concerned, 4 = very concerned, 5 = extremely concerned). OR 3. The target youth participated in counseling or another form of treatment (e.g., medication assisted treatment) because of a concern about alcohol, marijuana, or other substance use. EXCLUSION CRITERIA Youth: * Participated in previous iKinnect or WisePath for Teens research in the past 2 years Caregivers: * Participated in previous iKinnect or WisePath for Teens research in the past 2 years * Currently involved with the child protective service system due to a concern about child maltreatment (i.e., abuse or neglect).

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Conditions

The condition(s) this trial relates to.

substance abuse substance-related disorder Suicide

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adolescent Substance abuse Substance use Suicide

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Evidence-Based Practice Institute

    RECRUITING

    Seattle, Washington, 98126, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • University of Maryland, Baltimore

    RECRUITING

    Baltimore, Maryland, 21201, United States

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