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Glowing dye could make achalasia surgery safer

NCT ID NCT07181070

Knowledge-focused Sponsor: Federico II University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether a special green dye (indocyanine green) can help surgeons see and fix leaks during laparoscopic Heller-Dor surgery for achalasia, a condition that makes swallowing difficult. About 70 adults with type I or II achalasia will take part. The dye is injected during surgery to highlight any damage to the esophagus, so the surgeon can repair it immediately. The study also checks if this reduces the need for X-rays after surgery and compares recovery over 12 months.

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 (ICG) dye
What this could lead to
If it works, this could make achalasia surgery safer by helping surgeons spot and fix leaks right away, possibly avoiding extra X-rays.
What could go wrong
This is a small, early observational study with only 70 people. The dye may not clearly show all leaks, and results may not apply to everyone with achalasia.

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.

Participants

About 70 people

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

Started

Nov 2022

Expected to finish

Oct 2026

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.

Who is studied

Each patient has type I or type II esophageal achalasia and was treated with the Heller-Dor laparoscopic surgery.

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: * patients with achalasia of type I and II * patients undergoing laparoscopic Heller-Dor * patients older than 18 years Exclusion Criteria: * Patients \<18 years of age; * Uncooperative patients and/or patients unable to provide informed consent * ASA ≥4 * BMI ≥30 * Patients previously treated with other endoscopic/surgical procedures (botulinum toxin injections, dilation, POEM, myotomy) * Patients with achalasia type III * Patients with megaesophagus * Allergy to dyes or contrast agents included in the protocol (e.g., indocyanine green, barium, gastrografin)

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Conditions

The condition(s) this trial relates to.

achalasia Esophageal Achalasia

As listed by the trial registrant

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

Achalasia Achalasia, esophageal Indocyanine green Indocyanine green (ICG)

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

  • Università degli Studi di Napoli, Federico II

    RECRUITING

    Naples, Italy

More trials for these conditions

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