Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Surgeons test High-Tech headset for better views in the operating room

NCT ID NCT07164053

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests how well the MyVeo surgical headset shows surgical details during routine brain, spine, ear-nose-throat, or reconstructive surgeries. Surgeons will rate image quality, comfort, and safety while using the device. About 32 patients will take part, and no extra procedures or risks are added beyond standard care.

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 32 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The intended target population are patients undergoing a surgical procedure as defined within the intended purpose/indication for use of the respective compatible imaging system.

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: Candidates for the IMED-MyVeo study protocol must be appropriate patients for the applicable indication of use and have to fulfil the following inclusion criteria to be eligible for the recruitment of the study. 1. Participants must be 18 years of age or older at the time of signing the informed consent. 2. The participant or their legal representative must understand the study and have voluntarily signed and dated the Informed Consent Form, which has been approved by the Sponsor and the Ethics Committee for this study. 3. Diagnosed with condition requiring surgical intervention per user manual. GLOW400 Specific Inclusion Criteria 4. Participants must have a suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which requires surgical intervention. 5. The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use. GLOW800 Specific Inclusion Criteria 6. Participants must have a condition requiring surgical intervention in the cerebral vascular area as well as during plastic and reconstructive surgery. 7. The Indocyanine Green (ICG) cyanine dye is administered as a contrast agent per instructions for use. Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study. Exclusion Criteria: 1. Any uncontrolled systemic condition that may adversely affect the surgical outcome. 2. Individuals holding United States citizenship. GLOW400 Specific Exclusion Criteria 3. Known allergy to 5-ALA hydrochloride or protoporphyrin's. 4. Patients with porphyria (a condition characterized by the inability to break down protoporphyrin). GLOW800 Specific Exclusion Criteria 5. Known allergy to Indocyanine Green (ICG) cyanine dye. 6. Severe iodine-induced reactions to macromolecular iodine-containing compounds (e.g., iodinated contrast media, iodine-based antiseptics, or drugs like amiodarone), especially if the reaction involved anaphylaxis or respiratory compromise.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cerebral vascular conditions requiring surgical intervention are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • Hospital Germans Trias I Pujol

    Barcelona, Spain

  • University Hospital Basel

    Basel, Switzerland

More trials for these conditions

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