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Robot surgery vs. standard care for brain stem bleeding: a major trial begins

NCT ID NCT07300501

Disease control Sponsor: First Affiliated Hospital of Zhejiang University 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares robot-assisted surgery to standard medical care for people with a severe brain stem hemorrhage. The trial will enroll 300 patients in China to see if the surgery leads to better recovery and less disability after 3 months. The goal is to provide clear evidence on whether this risky procedure is worth doing.

What this could mean

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

Active substance
stereotactic aspiration surgery (robot-assisted)
What this could lead to
If successful, this could provide a proven surgical option to reduce disability and death from brain stem hemorrhage.
What could go wrong
This is an early-stage trial with no prior high-quality evidence. Surgery on the brain stem carries risks like infection or re-bleeding, and benefits are uncertain.

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 300 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 to 65 years

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: * Primary PBSH confirmed by CT/MRI, with hematoma volume \>5 ml; * Time from onset to hospital admission and diagnosis within 24 hours; * Glasgow Coma Scale (GCS) score of 4-8 (moderate to severe coma); * National Institutes of Health Stroke Scale (NIHSS) score ≥21 (severe neurological deficit); * Age between 18 and 65 years; * Presence of spontaneous respiration upon admission. Exclusion Criteria: * Hemorrhage caused by vascular malformation, cavernoma, or tumor stroke; * presence of severe comorbidities such as significant cardiac, hepatic, or renal insufficiency, or malignant tumors; * recent history of antiplatelet or anticoagulant medication use; * any condition expected to prevent completion of the 3-month follow-up.

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As listed by the trial registrant

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

Brain stem hematoma

How to take part

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

  1. The places running it

    11 sites. 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

  • Henan Provincial People's Hospital

    Zhengzhou, China

  • Nanfang Hospital, Southern Medical University

    Shenzhen, China

  • Qilu Hospital of Shandong University

    Jinan, China

  • Renji Hospital,School of Medicine,Shanghai Jiaotong University

    Shanghai, China

  • Shenzhen Second People's Hospital

    Shenzhen, China

  • Taizhou First People's Hospital

    Taizhou, China

  • The First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, China

  • Xiangya Hospital of Central South University

    Changsha, China

  • Xijing hospital

    Xi'an, China

  • Zhujiang Hospital,Southern Medical University

    Guangzhou, China