Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External DrainagEarly Phase 1NCT06486480
Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage
A Early Phase 1 study testing Using robot assisted endoscopy to clear intraventricular hemorrhage in people with Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag, run by Jin Hu.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag
- What is being tested?
- Using robot assisted endoscopy to clear intraventricular hemorrhage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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
- Being tested
- Using robot assisted endoscopy to clear intraventricular hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using robot assisted endoscopy to clear intraventricular hemorrhageProcedure or surgery
Also called External ventricular drainage
More advanced surgical auxiliary instruments are used to improve surgical accuracy
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted endoscopy group | Experimental | Using robot assisted endoscopy to clear intraventricular hemorrhage Receives: Procedure: Using robot assisted endoscopy to clear intraventricular hemorrhage |
| External ventricular drainage group | Active comparator | Using External ventricular drainage to clear intraventricular hemorrhage Receives: Procedure: Using robot assisted endoscopy to clear intraventricular hemorrhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month mRS score
MRS Scores 6 months after onset
Measured: 180 days
Secondary outcomes (1)
30 day mortality rate
Mortality at 30 days after onset
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External DrainagStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Hu, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486480
- Sponsor's protocol ID
- HSSJWK202406
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage
- ClinicalTrials.gov ID
- NCT06486480
- Acronym / sponsor ID
- HSSJWK202406
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Jin HuUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot assisted endoscopy group | Experimental | Procedure: Using robot assisted endoscopy to clear intraventricular hemorrhageUsing robot assisted endoscopy to clear intraventricular hemorrhage |
| External ventricular drainage group | Active comparator | Procedure: Using robot assisted endoscopy to clear intraventricular hemorrhageUsing External ventricular drainage to clear intraventricular hemorrhage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range from 18 to 80 years old;
- ⑤ First CT to surgery time<72 hours;
- ⑥ GCS ≤ 14.
Key exclusion criteria (10 listed)
- ① Suspected (unless excluded by angiography or CTA/MRA/MRI) or untreated rupture of cerebral aneurysm, Moyamoya disease, intracranial AVM rupture, or tumor;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using robot assisted endoscopy to clear intraventricular hemorrhageAlso: External ventricular drainageMore advanced surgical auxiliary instruments are used to improve surgical accuracy | Procedure or surgery | External ventricular drainage group, Robot assisted endoscopy group |
Primary outcome
6-month mRS score
Time frame: 180 days
MRS Scores 6 months after onset
1 secondary outcome
30 day mortality rate
Time frame: 0-30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Using robot assisted endoscopy to clear intraventricular hemorrhage in people with Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag, run by Jin Hu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month mRS score (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.