Blood PressureNCT03805815
Clinical Implication of the Tunable Crack Sensor
An observational study of Blood Pressure, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
[Development of diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive membrane: a pilot study] Comparison of blood pressure via tunable crack sensor and invasive pressure wire Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- tunable crack sensor
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Sep 2018to 1 Aug 2019
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A case of suspected coronary artery disease for the purpose of coronary angiography
Who may be able to join
- A case of suspected coronary artery disease at Seoul National University Hospital for the purpose of coronary angiography
- At least 19 years old
- If he/she hears enough explanation about clinical research and intends to participate in clinical research himself
Who cannot join
- Under 19 years old
- Refusal to participate in clinical studies
- If the cognitive function is weak enough not to understand the explanation of the clinical study and to make voluntary decisions accordingly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Diagnosis Algorism for Paroxysmal Arrhythmia Using Ultra-thin Resistive Membrane: a Pilot Study
[Development of diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive membrane: a pilot study] Comparison of blood pressure via tunable crack sensor and invasive pressure wire
Read the detailed description
To develop a diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive membrane, we will compare the blood pressure measured via a tunable crack sensor and that measured by a invasive pressure wire
- Conditions
- Blood Pressure
- Being tested
- tunable crack sensor
- Keywords
- blood pressure, crack sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tunable crack sensorDevice
blood pressure monitoring via crack sensor
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure monitoring using tunable crack sensor
Systolic blood pressure and diastolic blood pressure by using tunable crack sensor
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start10 Sep 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805815
- Sponsor's protocol ID
- H-1808-177-969
- Status last verified
- Jan 2019
- First submitted
- 30 Dec 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kang D, Pikhitsa PV, Choi YW, Lee C, Shin SS, Piao L, Park B, Suh KY, Kim TI, Choi M. Ultrasensitive mechanical crack-based sensor inspired by the spider sensory system. Nature. 2014 Dec 11;516(7530):222-6. doi: 10.1038/nature14002.
PubMed 25503234
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Diagnosis Algorism for Paroxysmal Arrhythmia Using Ultra-thin Resistive Membrane: a Pilot Study
- ClinicalTrials.gov ID
- NCT03805815
- Acronym / sponsor ID
- H-1808-177-969
- Conditions
- Blood Pressure
- Keywords
- blood pressure, crack sensor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 16 Jan 2019 (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.
[Development of diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive membrane: a pilot study] Comparison of blood pressure via tunable crack sensor and invasive pressure wire
Detailed description
To develop a diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive membrane, we will compare the blood pressure measured via a tunable crack sensor and that measured by a invasive pressure wire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A case of suspected coronary artery disease for the purpose of coronary angiography
Key inclusion criteria (3 listed)
- A case of suspected coronary artery disease at Seoul National University Hospital for the purpose of coronary angiography
- At least 19 years old
- If he/she hears enough explanation about clinical research and intends to participate in clinical research himself
Key exclusion criteria (3 listed)
- Under 19 years old
- Refusal to participate in clinical studies
- If the cognitive function is weak enough not to understand the explanation of the clinical study and to make voluntary decisions accordingly
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 |
|---|---|---|
| tunable crack sensorblood pressure monitoring via crack sensor | Device | – |
Primary outcome
Blood pressure monitoring using tunable crack sensor
Time frame: immediately
Systolic blood pressure and diastolic blood pressure by using tunable crack sensor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Background: PubMed 25503234Kang D, Pikhitsa PV, Choi YW, Lee C, Shin SS, Piao L, Park B, Suh KY, Kim TI, Choi M. Ultrasensitive mechanical crack-based sensor inspired by the spider sensory system. Nature. 2014 Dec 11;516(7530):222-6. doi: 10.1038/nature14002.
- Individual participant dataSharing planned: Undecided
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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.
Bon-Kwon Koo principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
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?
Blood pressure monitoring using tunable crack sensor (time frame: immediately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805815, which also lists 1 linked publication.
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 16 Jan 2019.