A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET）

February 21, 2025 updated by: MicroPort NeuroTech Co., Ltd.
This clinical trial is a prospective, open-label, single-arm clinical trial. According to the inclusion and exclusion criteria specified in the trial protocol, no fewer than 16 subjects with cerebral hemorrhage will be enrolled in 1 to 2 clinical centers. Considering the learning period required for doctor to become proficient in using the device, the first three cases at each research center are considered as the lead-in period cases and will not be included in the primary analysis dataset. During the surgery, a disposable intracerebral aspiration endoscope will be used to remove the intracerebral hematoma. Follow-ups will be conducted at discharge/Day 7 (±1 day), postoperative 1 month (±7 days), and postoperative 3 months (±15 days). Recording various indicators to evaluate the safety and effectiveness of the disposable intracerebral aspiration endoscope in treating intracerebral hematoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guizhou
      • GuiYang, Guizhou, China
        • Recruiting
        • Affiliated Hospital of Guizhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 80 years old;
  2. Spontaneous intracerebral hemorrhage;
  3. Hemorrhage located in the supratentorial subcortical or basal ganglia region;
  4. Hematoma volume ≥ 30ml and ≤ 80ml;
  5. Able to undergo surgery within 72 hours after onset;
  6. GCS score of 5 to 14;
  7. The subject themselves and/or their authorized representative can understand the purpose of the study, agree to participate, and sign the informed consent form.

Exclusion Criteria:

  1. History of intracerebral hemorrhage within the past year;
  2. Traumatic intracerebral hemorrhage;

  3. Multiple intracerebral hemorrhages;

    Note: Hemorrhage in the supratentorial subcortical or basal ganglia region that extends into the ventricles is not considered multiple hemorrhages and can be included.

  4. Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;
  5. Formation of brain herniation;
  6. Severe neurological or psychiatric disorders before onset (such as epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, depression, etc.);
  7. mRS score ≥ 3 before onset;
  8. Use of anticoagulants or antiplatelet drugs within 14 days before onset, or the need for long-term use of anticoagulants or antiplatelet drugs, or other factors causing coagulation dysfunction;
  9. Platelet count less than 100 × 10^3/μL or international normalized ratio (INR) greater than 1.4;
  10. Active bleeding present, such as gastrointestinal bleeding, respiratory bleeding, or subcutaneous hematoma;
  11. Uncontrolled hypertension that cannot be managed with medication (systolic blood pressure > 220 mmHg or diastolic blood pressure > 120 mmHg after medication upon admission);
  12. Severe systemic diseases that cannot tolerate surgery, such as severe liver or kidney dysfunction;
  13. Women of childbearing age who are pregnant or breastfeeding;
  14. Currently participating in any drug or device research, or planning to participate in other drug or device clinical trials;
  15. Life expectancy ≤ 1 year;
  16. Other situations where the researcher deems the subject unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Endoscopic surgery
Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma
Procedure: Endoscopic surgery
Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intracerebral hematoma clearance rate
Time Frame: Day 0（within 24 hours after procedure）
Perform a brain CT scan within 24 hours after surgery, comparing it with the baseline CT, and calculating the proportion of hematoma volume reduction.
Day 0（within 24 hours after procedure）

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Hospitalization duration
Time Frame: During the days at hospital(up to 105 days)
During the days at hospital(up to 105 days)
Intensive Care Unit(ICU) duration
Time Frame: During the days at Intensive Care Unit(ICU)(up to 105 days)
During the days at Intensive Care Unit(ICU)(up to 105 days)
The proportion of subjects with an mRS score of ≤3 at 3 months after surgery
Time Frame: 3 months after surgery(±15days)
3 months after surgery(±15days)
The incidence of rebleeding at the surgical site within 7 days after surgery or before discharge.
Time Frame: 7 days (±1day) after surgery or before discharge.
7 days (±1day) after surgery or before discharge.
The incidence of reoperation due to rebleeding at the surgical site during the follow-up period.
Time Frame: 3 months after surgery(±15days)
3 months after surgery(±15days)
All-cause mortality
Time Frame: 3 months after surgery(±15days)
3 months after surgery(±15days)
Device-related SAE
Time Frame: 3 months after surgery(±15days)
3 months after surgery(±15days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MicroPort NeuroTech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NeuroFlash-2024-01-CIP-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings