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NCT06486480 | NOT YET RECRUITING | Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag

Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage
Sponsor:

jin hu

Information provided by (Responsible Party):

jin hu

Brief Summary:

Clarify the therapeutic differences between robot assisted endoscopic clearance and traditional puncture and external drainage, and establish a new minimally invasive surgical diagnosis and treatment strategy for intraventricular hemorrhage

Condition or disease

Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag

Intervention/treatment

Using robot assisted endoscopy to clear intraventricular hemorrhage

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 143 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage
Actual Study Start Date : 2025-01-01
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age range from 18 to 80 years old;
  • * The time from onset to first CT confirmation of intraventricular hemorrhage is less than 24 hours;
  • * Before enrollment, CT confirmed that the intraventricular hemorrhage score (modified Graeb score) was ≥ 8 points, and the total score of bilateral lateral ventricles was ≥ 5 points;
  • * If there is concurrent cerebral hemorrhage but the hematoma volume is less than 30ml;
  • ⑤ First CT to surgery time\<72 hours;
  • ⑥ GCS ≤ 14.
Exclusion Criteria
  • * ① Suspected (unless excluded by angiography or CTA/MRA/MRI) or untreated rupture of cerebral aneurysm, Moyamoya disease, intracranial AVM rupture, or tumor;
  • * Patients with a GCS score of 3 and/or fixed dilated pupils and/or no spontaneous breathing;
  • * Patients with pre-existing neurological disorders that affect neurological function assessment prior to onset;
  • * Coagulation dysfunction;
  • * Patients who require long-term anticoagulant treatment;
  • ⑥ Use dabigatran, apixaban, and/or rivaroxaban (or drugs of the same class) before symptoms appear; ⑦ Platelet count\<100 × 109/L, INR\>1.4;
  • ⑧ Pregnancy (positive serum or urine pregnancy test);
  • ⑨ Subtentorial hemorrhage or brainstem hemorrhage;
  • ⑩ Patients who have previously participated in other interventional clinical studies and participated in observational, natural history, and/or epidemiological studies that do not involve intervention are eligible;
  • ⑪ Subjects who are expected to not survive until the 180th day of visit; No written informed consent was given by the subjects or legal representatives.
Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage

Location Details

NCT06486480

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