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New ultrasound gel aims to sharpen brain surgery views

NCT ID NCT07042620

Knowledge-focused Sponsor: SonoClear AS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new ultrasound system (SonoClear®) that uses a special gel to mimic brain tissue, aiming to give surgeons clearer images during brain tumor removal. Fifteen adults with glioma (a type of brain tumor) are participating. The main goal is to see if the new system reduces image noise and improves picture quality compared to standard methods, while also checking for any safety issues up to 6 months after surgery.

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 15 people

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

Started

Feb 2026

Expected to finish

Nov 2026

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.

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.

Key Inclusion Criteria: * A diffuse malignant glial tumour (high grade (grade III and IV) or low grade (grade I-II)) is suspected from the diagnostic MRI scan * Pre- or peri-procedural confirmed histopathology of glioma * ≥18 years of age * Karnofsky performance status ≥ 70 * Life expectancy of more than 30 days at the time of procedure * Negative pregnancy test for female subjects of childbearing potential Key Exclusion Criteria: * Not able to give consent (e.g., severe cognitive impairment) * History of brain radiation therapy * Recent meningitis (within 6 months prior to screening visit) * Other active infection (within 30 days prior to screening visit) * Immuno-incompetent patient (e.g., failing immune system due to AIDS) * Patients taking immune-suppressive medication * Intended biopsy only (meaning cases not suitable for resection) * Known hypersensitivity to egg protein * Known hypersensitivity to soybean or peanut protein * Known Hypersensitivity to glycerol * Pregnant or lactating females or females who intend to become pregnant during the time of the study

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Conditions

The condition(s) this trial relates to.

brain cancer glioblastoma glioma low grade glioma malignant glioma

As listed by the trial registrant

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

Brain tumor adult Glioblastoma Low grade glioma (LGG), high grade glioma (HGG)

Contacts and locations

Locations

  • Bezirkskrankenhaus Günzburg

    Günzburg, 89312, Germany

  • Eberhard Karls Universität Tübingen, Faculty of Medicine, Department of Neurosurgery

    Tübingen, 72076, Germany

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, 78052, Germany

  • Universitätsklinikum Gießen und Marburg GmbH Standort Marburg

    Marburg, 35033, Germany

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