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New camera aims to spot stomach and bowel diseases without a biopsy

NCT ID NCT04565704

Knowledge-focused Sponsor: Massachusetts General Hospital 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new optical imaging device that takes pictures of tissue samples from the stomach and colon during routine endoscopy. The goal is to see if the device can detect signs of disease without needing to remove tissue for a traditional biopsy. Researchers will compare the images to standard lab results to see if the device works well enough for future use. The study involves 200 adults already scheduled for an endoscopy or colonoscopy.

What this could mean

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

Active substance
Optical imaging device
What this could lead to
If successful, this could lead to a non-invasive tool that helps doctors diagnose gastrointestinal diseases more quickly and accurately during routine endoscopy.
What could go wrong
This is an early feasibility study with only 200 participants, so the device may not work as hoped or may not be better than current methods. It is not yet tested for treatment or cure.

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 200 people

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

Started

Mar 2016

Expected to finish

Dec 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

Accepted

You do not need to have the condition being studied to take part.

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: • Scheduled for an elective esophagoduodenoscopy and/or colonoscopy Exclusion Criteria: • According to standard of care at MGH endoscopy department.

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Conditions

The condition(s) this trial relates to.

digestive system disorder

As listed by the trial registrant

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

Gastrointestinal disease Gastrointestinal dysfunction

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.