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3D-Printed guides could make thyroid eye surgery safer

NCT ID NCT04662190

Disease control Sponsor: Althaia Xarxa Assistencial Universitària de Manresa 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether using 3D-printed, custom models to plan and guide orbital decompression surgery leads to fewer complications and better outcomes for people with thyroid eye disease. Twelve adults with inactive, moderate-to-severe disease were randomly assigned to receive either 3D-printed assisted surgery or standard surgery. The researchers measured complications and eye position changes.

What this could mean

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

Active substance
3D-printed model and guide for surgery planning
What this could lead to
If successful, this approach could make orbital decompression surgery safer and more precise for people with thyroid eye disease.
What could go wrong
This is a very small, early study (12 people) testing a surgical tool, not a new treatment. The benefits may not be large or generalizable.

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

12 people

The number who actually took part.

Started

Jul 2021

Finished

Mar 2026

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: * Diagnosis of inactive thyroid-associated orbitopathy requiring bilateral orbital decompression (moderate-severe in EUGOGO classification). * Volunteers older than 18 years old. * Ability to read. * Acceptation to participate and signature of informed consent. Exclusion Criteria: * Younger than 18 years old. * Previous orbital surgery. * Any coexisting disease preventing follow-up.

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

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

Surgical procedure, unspecified Thyroid associated ophthalmopathy

Contacts and locations

Locations

  • Eduard Pedemonte Sarrias

    Manresa, Barcelona, 08243, Spain

More trials for these conditions

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