Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage

NCT04957862 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2022-08-10

No results posted yet for this study

Summary

Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage for Accelerating Functional Rehabilitation (RESCUE-CHAIN): a Multi-center Randomized Controlled Trial

Conditions

  • Hypertensive Intracerebral Hemorrhage

Interventions

PROCEDURE

Robotic Assisted Evacuation

On the day of surgery, the patient is placed in the prone position. After the Mayfield skull clamp is positioned to reduce interference, the videometric tracker of robot will automatically scan the preliminary markers to complete patient-to-image registration. Following the registration, the robotic arm will move on command according to the planned puncture trajectory and stop at a defined distance to the marked target point. The entry point is marked on the scalp along the puncture trajectory, then a scalp incision and burr-hole drilling will be performed. After penetrating the dura with unipolar electrocautery, a drainage tube will be gently inserted to the defined depth under the indication of the disinfected robotic arm. The liquefied hematoma will be withdrawn slowly by a 10 mL syringe.

Sponsors & Collaborators

  • Beijing Tian Tan Hospital Affiliated to Capital Medical University

    collaborator UNKNOWN
  • Tianjin Medical University General Hospital

    collaborator OTHER
  • Peking Union Medical College Hospital

    collaborator OTHER
  • First Affiliated Hospital of Harbin Medical University

    collaborator OTHER
  • Renmin Hospital of Wuhan University

    collaborator OTHER
  • South Taihu Hospital of Huzhou

    collaborator UNKNOWN
  • Qian Xi Nan People's Hospital

    collaborator UNKNOWN
  • Huazhong University of Science and Technology Union Hospital (Nanshan Hospital)

    collaborator UNKNOWN
  • Fujian Provincial Hospital

    collaborator OTHER
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • LanZhou University

    collaborator OTHER
  • Anhui No.2 Provincial People's Hospital

    collaborator UNKNOWN
  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER
  • Jinjiang Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN
  • Tang-Du Hospital

    collaborator OTHER
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER
  • Shenzhen People's Hospital

    collaborator OTHER
  • Shaanxi Provincial People's Hospital

    collaborator OTHER
  • Shanghai 6th People's Hospital

    collaborator OTHER
  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER
  • Sanhe Yanjiao People's Hospital

    collaborator UNKNOWN
  • General Hospital of Ningxia Medical University

    collaborator OTHER
  • Affiliated Hospital of Chifeng University

    collaborator UNKNOWN
  • Haikou People's Hospital

    collaborator OTHER
  • Qilu Hospital of Shandong University

    collaborator OTHER
  • Xiangya Hospital of Central South University

    collaborator OTHER
  • Shanghai Changzheng Hospital

    lead OTHER

Principal Investigators

  • Lijun Hou, MD,PhD · Shanghai Changzheng Hospital

  • Tao Xu, MD,PhD · Shanghai Changzheng Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-12-31
Completion
2025-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04957862 on ClinicalTrials.gov