ThrombosisNCT04644653
Ex Vivo Test of New Stroke Treatment Using Magnetic Nanorobots
An observational study of Thrombosis, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Tissue plasminogen activator (tPA) is the FDA approved thrombolytic drug for patients with acute ischemic stroke. While transcatheter endovascular therapy is widely accepted as an effective method for targeted blood vessels via a catheter to elicit ischemic necrosis. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- How many people
- 100 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Sep 2020to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * Healthy pregnant women at 20-45 years of age of any ethic origin, giving childbirth with natural delivery or caesarean sections after 37-42 weeks of gestation. * Healthy singleton pregnancy. * Participant able to give voluntary, written, informed consent to participate in the study.
Who may be able to join
- Healthy pregnant women at 20-45 years of age of any ethic origin, giving childbirth with natural delivery or caesarean sections after 37-42 weeks of gestation.
- Healthy singleton pregnancy.
- Participant able to give voluntary, written, informed consent to participate in the study.
Who cannot join
- Abnormal prenatal development (e.g intrauterine growth restriction)
- Early preterm birth < 37 weeks
- Verbal Confirmation of hypercholesterolemia
- Family history of stroke or vascular disease
- Type I or Type II diabetes and gestational diabetes
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative.
Show all 10Show fewer
- Clinically significant abnormal laboratory results at screening.
- Any other active or unstable medical condition.
- History of liver disease.
- History of hypertension (including pre-eclampsia)
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 1 recruiting
- Active, not recruiting
Advanced Nanomaterials & Microrobotics Laboratory, Room 202, William M.W Mong Engineering Building, CUHK and Room 508, Li Ka Shing Medical Sciences Building, Prince of Wales Hospital
Shatin, New Territories
- Recruiting
Department of Obstetrics and Gynaecology, Prince of Wales Hospital
Shatin, New Territories
Pui Wah Chung, Doctor, (852) 35051537, jacquelinechung@cuhk.edu.hk
Pui Wah Chung, Doctor
About this study
Official title: Steered t-PA Delivery for Thrombolysis Test Using Magnetic Swarming Nanorobots on Human Placenta as an ex Vivo Model of Human Cerebral Vascular System
Tissue plasminogen activator (tPA) is the FDA approved thrombolytic drug for patients with acute ischemic stroke. While transcatheter endovascular therapy is widely accepted as an effective method for targeted blood vessels via a catheter to elicit ischemic necrosis.
To improve targeting accuracy administrated tPA and avoiding collateral tissue damage, we developed a magnetic nanorobotic system to active system to active intravenous delivery of tPA for targeted thrombus removal. Here human placenta will be used as an ex vivo model for human cerebral vascular system in our ex vivo thrombolysis study. Our magnetic nanorobotic system encapsulated with tPA overcomes the limitations of passive thrombolytic therapy with tPA alone and will be a promising approach for the treatment of ischemic stroke and other thrombotic diseases
- Conditions
- Thrombosis
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombolysis performance
Size of thrombus by angiography, mm
Measured: 1 -2 hours
Time for recanalization
Time for recanalization of occluded vessels, mins
Measured: 1 -2 hours
Damage to vessels
Histological damage evaluation. The vessels are sectioned and stained with H\&E stain
Measured: 1 -2 hours
Secondary outcomes (3)
Stability of magnetic nanorobots
Controllability of the magnetic nanorobots. The loss in mass of nanorobots after magetic navigation in blood vessels is measured.
Measured: 1 - 2 hours
Dosage requirement
Dosage requirement of nanorobots and thus t-PA, mg
Measured: 1 - 2 hours
Distribution of administrated nanorobots
The distribution of administrated nanorobots. The position of nanorobots is tracked by MRI.
Measured: 1 - 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Sep 2020
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHANG Li, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644653
- Sponsor's protocol ID
- 2020.384
- Status last verified
- Mar 2022
- First submitted
- 19 Nov 2020
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steered t-PA Delivery for Thrombolysis Test Using Magnetic Swarming Nanorobots on Human Placenta as an ex Vivo Model of Human Cerebral Vascular System
- ClinicalTrials.gov ID
- NCT04644653
- Acronym / sponsor ID
- 2020.384
- Conditions
- Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Nov 2020 (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.
Tissue plasminogen activator (tPA) is the FDA approved thrombolytic drug for patients with acute ischemic stroke. While transcatheter endovascular therapy is widely accepted as an effective method for targeted blood vessels via a catheter to elicit ischemic necrosis.
To improve targeting accuracy administrated tPA and avoiding collateral tissue damage, we developed a magnetic nanorobotic system to active system to active intravenous delivery of tPA for targeted thrombus removal. Here human placenta will be used as an ex vivo model for human cerebral vascular system in our ex vivo thrombolysis study. Our magnetic nanorobotic system encapsulated with tPA overcomes the limitations of passive thrombolytic therapy with tPA alone and will be a promising approach for the treatment of ischemic stroke and other thrombotic diseases
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Healthy pregnant women at 20-45 years of age of any ethic origin, giving childbirth with natural delivery or caesarean sections after 37-42 weeks of gestation. * Healthy singleton pregnancy. * Participant able to give voluntary, written, informed consent to participate in the study.
Key inclusion criteria (3 listed)
- Healthy pregnant women at 20-45 years of age of any ethic origin, giving childbirth with natural delivery or caesarean sections after 37-42 weeks of gestation.
- Healthy singleton pregnancy.
- Participant able to give voluntary, written, informed consent to participate in the study.
Key exclusion criteria (10 listed)
- Abnormal prenatal development (e.g intrauterine growth restriction)
- Early preterm birth < 37 weeks
- Verbal Confirmation of hypercholesterolemia
- Family history of stroke or vascular disease
- Type I or Type II diabetes and gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thrombolysis performance
Time frame: 1 -2 hours
Size of thrombus by angiography, mm
Time for recanalization
Time frame: 1 -2 hours
Time for recanalization of occluded vessels, mins
Damage to vessels
Time frame: 1 -2 hours
Histological damage evaluation. The vessels are sectioned and stained with H\&E stain
3 secondary outcomes
Stability of magnetic nanorobots
Time frame: 1 - 2 hours
Dosage requirement
Time frame: 1 - 2 hours
Distribution of administrated nanorobots
Time frame: 1 - 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Department of Obstetrics and Gynaecology, Prince of Wales Hospital
Shatin, Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombolysis performance (time frame: 1 -2 hours). The study lists 3 primary outcomes in all. 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 24 Mar 2022.