NCT06484374

Brief Summary

This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracranial hematoma evacuation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 17, 2026

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

June 26, 2024

Last Update Submit

February 12, 2026

Conditions

Hematoma BrainLarge Basal Ganglia Hemorrhage

Keywords

Large Basal Ganglia HemorrhageAl-assisted robotic guidancemulticenterRandomlzedcontrolledumbrella trial

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale (mRS) score at 6 months

    The primary analysis will compare differences between the two groups based on utility-weighted mRS.

    up to 6 months

Secondary Outcomes (11)

  • Ordinal shift in mRS scores at 6 months (ordinal shift)

    up to 6 months

  • Favorable functional outcome at 6 months (mRS 0-1)

    up to 6 months

  • Functional independence at 6 months (mRS 0-2)

    up to 6 months

  • Health-related quality of life (HRQoL) at 6 months, assessed by the EQ-5D-5L questionnaire

    up to 6 months

  • Total length of hospital stay

    up to 6 months

  • +6 more secondary outcomes

Study Arms (2)

Robot-Assisted Endoscopic Minimally Invasive Surgery

EXPERIMENTAL

Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure. Surgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma. Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded

Procedure: Robot-Assisted Endoscopic Minimally Invasive Surgery

Traditional Surgical Approaches

SHAM COMPARATOR

A small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap.

Procedure: Traditional Surgical Approaches

Interventions

Robot-Assisted Endoscopic Minimally Invasive SurgeryPROCEDURE

Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure. Surgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma. Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded b

Robot-Assisted Endoscopic Minimally Invasive Surgery
Traditional Surgical ApproachesPROCEDURE

A small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap.

Traditional Surgical Approaches

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years at randomization;
  • Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
  • Hematoma volume ≥30 mL prior to randomization;
  • Glasgow Coma Scale (GCS) score ≥ 5;
  • Available for surgery within 72 hours after onset;
  • Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage;
  • Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.

You may not qualify if:

  • Hematoma involving the thalamus (volume \>5 mL or diameter \>2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;
  • Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation of ischemic infarcts; or recent (within 1 year) recurrence of intracerebral hemorrhage;
  • Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;
  • Any irreversible coagulation disorder or known coagulopathy; platelet count \<100,000; INR \>1.4; or use of anticoagulant medication within 7 days before the current hemorrhage;
  • Current or probable pregnancy;
  • Patients with concurrent severe illness likely to influence outcome assessment;
  • Difficulty in follow-up or poor compliance due to any cause.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, China

RECRUITING

Central Study Contacts

Chun-Hua Hang, PhD

CONTACT

025-83106666hang_neurosurgery@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The intervention group will undergo robot-assisted endoscopic hematoma evacuation, while the control group will receive traditional surgical approaches (such as small craniotomy or large-bone-flap intracranial hematoma evacuation).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

December 20, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 17, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)