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Green dye could help surgeons prevent stomach ulcers after bypass

NCT ID NCT06002906

Symptom relief Sponsor: University Health Network, 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a safe green dye, injected during gastric bypass surgery, can help surgeons see blood flow to the new stomach connection. Poor blood flow can lead to ulcers, leaks, or narrowing. The trial involves 300 adults and will follow them for two years to see if using the dye reduces these complications.

What this could mean

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

Active substance
indocyanine green (a green dye injected into the bloodstream to highlight blood flow during surgery)
What this could lead to
If it works, this dye could help surgeons spot poor blood flow during gastric bypass, potentially lowering the risk of ulcers, leaks, and other complications.
What could go wrong
This is a pilot study, so it's early and small. The dye's benefit is not proven yet, and it may not reduce complication rates in practice.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 300 people

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

Started

Jan 2023

Expected to finish

Jul 2027

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: * Capacity to provide informed consent. * Over the Age of 18. * Eligible for bariatric surgery in Ontario and deemed an appropriate candidate for RYGB surgery by the bariatric program. * Commit to follow-up within the bariatric program, including behavioral and dietary modifications designed to aid in sustained weight-loss. * Treatment of marginal ulcer with the revisional surgery. Exclusion Criteria: * Not willing to participate in study * Contraindication to, or not planned to undergo RYGB * Known allergy to indocyanine green or Sodium Iodide * Is participant pregnant or planning to get pregnant in next two years * Ongoing substance abuse or active smoking * Bleeding diathesis or Coagulopathy * Unwilling to take PPI medication Post operatively

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Conditions

The condition(s) this trial relates to.

gastric ulcer morbid obesity

As listed by the trial registrant

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

Obesity, morbid Ulcer, gastric

Contacts and locations

Locations

  • Toronto Western Hospital, University Health Network

    Toronto, Ontario, M5T2S8, Canada

More trials for these conditions

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