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Smart bottle cap could reveal hidden missed doses in GERD patients

NCT ID NCT07712614

Disease control Sponsor: Cosmos Rx, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether a digital bottle cap called FORTISKAP™ can detect missed doses of proton pump inhibitors (PPIs) in people with GERD more accurately than standard methods like pharmacy fill records or patient questionnaires. Fifty adults with GERD who take a daily PPI will use the cap for 90 days, which records each bottle opening. The goal is to see if real-time tracking catches non-adherence that other measures miss.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fortiskap bottle-top medication monitor (a digital cap that records bottle openings)
What this could lead to
If successful, this device could give doctors a more accurate way to spot when patients skip their GERD medication, potentially improving treatment outcomes.
What could go wrong
This is a small, early study (50 people) comparing a device to existing methods, not testing a new treatment. The device may not work for everyone or may be inconvenient to use long-term.

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 50 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

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

18 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: Age ≥ 21 years at time of enrollment Confirmed diagnosis of GERD and/or erosive esophagitis documented in the Epic medical record (ICD-10 code K21.0 or K21.9) Currently prescribed a once-daily oral PPI (omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, or dexlansoprazole) for a minimum of 30 days prior to enrollment Willing and able to fill PPI prescription exclusively at TidalHealth Community Pharmacy for the 90-day study period Owns a smartphone (iOS or Android) capable of running the FORTISKAP™ companion application Able to participate in the study enrollment and ongoing requirements in English. Exclusion Criteria: Current diagnosis of active esophageal malignancy, gastric malignancy, or other upper gastrointestinal malignancy requiring active systemic treatment Cognitive impairment, dementia, or other neurological condition that, in the judgment of the Site PI, would prevent proper use of the FORTISKAP™ device or completion of self-report questionnaires Institutionalized subjects (nursing home, assisted living, correctional facility) or subjects whose medications are managed by a caregiver who would need to operate the device on their behalf Life expectancy \< 6 months in the judgment of the treating physician

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease Medication Adherence peptic esophagitis

As listed by the trial registrant

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

GERD (gastroesophageal reflux disease)

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

    1 site. 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

Locations

  • Tidal Health

    Salisbury, Maryland, 21801, United States

    Contact Email: •••••@•••••

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