NCT06486480

Not Yet RecruitingEarly Phase 1

Effect of Minimally Invasive Surgical Assisted by Robots on ...

Jin Hu Source

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Other study identifiers

Sponsor study identifier

HSSJWK202406

Study Type

interventional

Estimated enrollment

143

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: not yet recruiting
Estimated enrollment: 143 participants
Study completion date: December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 27, 2024
Actual (reported)
First Posted
July 3, 2024
Actual (reported)
Study Start
January 1, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: July 3, 2024
Status Verified: June 2024
Last Update Submitted: June 27, 2024

Conditions

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

Outcome Measures

Primary Outcomes (1)

6-month mRS score
MRS Scores 6 months after onset
180 days

Secondary Outcomes (1)

30 day mortality rate
0-30 days

Study Arms (2)

Robot assisted endoscopy group

EXPERIMENTAL

Using robot assisted endoscopy to clear intraventricular hemorrhage

Procedure: Using robot assisted endoscopy to clear intraventricular hemorrhage

External ventricular drainage group

ACTIVE COMPARATOR

Using External ventricular drainage to clear intraventricular hemorrhage

Procedure: Using robot assisted endoscopy to clear intraventricular hemorrhage

Interventions

Using robot assisted endoscopy to clear intraventricular hemorrhageProcedure

More advanced surgical auxiliary instruments are used to improve surgical accuracy

Also known as: External ventricular drainage

External ventricular drainage groupRobot assisted endoscopy group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age range from 18 to 80 years old;
The time from onset to first CT confirmation of intraventricular hemorrhage is less than 24 hours;

Sponsors & Collaborators

Jin Hu
Otherlead

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Huashan Hospital, Fudan University

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 3, 2024

Study Start

January 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

July 3, 2024

Record last verified: 2024-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06486480
Data provider: ClinicalTrials.gov
Source updated: 2024-07-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:14 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Robot assisted endoscopy group

External ventricular drainage group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Design

Study Record Dates

You may not qualify if:

Source record