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Video and AI take on the consent form — can technology boost patient understanding before a complex procedure?

NCT ID NCT07723105

Knowledge-focused Sponsor: Unity Health Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether a digital-supported consent process — including a procedure-specific educational video and an offline AI question-answering tool — helps patients better understand the risks, benefits, and alternatives of advanced therapeutic endoscopy. Adult patients scheduled for elective advanced endoscopy are randomly assigned to either standard physician-led consent or the digital pathway. The main goal is to measure patient comprehension before the procedure, along with anxiety, satisfaction, and decision-making confidence.

What this could mean

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

Active substance
a digital-supported consent pathway including an educational video and an AI-based question-answering tool
What this could lead to
If it works, this could point toward a more effective and consistent way to help patients understand complex medical procedures before giving consent.
What could go wrong
This is a relatively small trial focused on comprehension, not on clinical outcomes. The digital tool may not improve understanding for all patients, and the AI component may struggle with nuanced questions.

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 180 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

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Adults aged 18 years or older * Scheduled to undergo elective advanced therapeutic endoscopy * Able to provide informed consent for study participation * Able to engage with study materials in a language supported by the site * Willing and able to complete study questionnaires and follow-up assessments Exclusion Criteria: * Emergent or urgent procedures where the consent process cannot reasonably incorporate the study intervention * Inability or unwillingness to provide informed consent for study participation * Requirement for substitute decision-maker consent for the procedural decision itself, if this precludes meaningful use of the study intervention * Severe cognitive, visual, hearing, or communication limitations not adequately accommodated by site resources * Inability to complete the planned pre-procedural assessments * Prior enrollment in this study for the same procedural episode * Any clinical situation in which the treating endoscopist determines that study participation would be unsafe or inappropriate

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Conditions

The condition(s) this trial relates to.

Patient Satisfaction

As listed by the trial registrant

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

Digital health Informed consent Patient comprehension Patient education Therapeutic endoscopy

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • St. Michael's Hospital - Unity Health Toronto

    Toronto, Ontario, M5B 1W8, Canada

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