Clinical Implication of the Tunable Crack Sensor | NCT03805815

Studies
Clinical Implication of the Tunable Crack Sensor

NCT03805815

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jan 16, 2019Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Blood Pressure

Interventions

tunable crack sensor

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2018Actual

Primary Completion Date

Mar 1, 2019Estimated

Completion Date

Aug 1, 2019Estimated

First Submitted Date

Dec 30, 2018

First Submission Date that Met QC Criteria

Jan 14, 2019

First Posted Date

Jan 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2019

Last Update Posted Date

Jan 16, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bon-Kwon Koo, Professor of Medicine / Cardiology, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tunable crack sensor	Device	blood pressure monitoring via crack sensor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure monitoring using tunable crack sensor	Systolic blood pressure and diastolic blood pressure by using tunable crack sensor	immediately

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A case of suspected coronary artery disease for the purpose of coronary angiography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bon-Kwon Koo	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul national university hospital		Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25503234	Background	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.