An Optical System for Measuring Blood Pressure

NCT03042949 | Unknown

• 1 other identifier: 0265-16-MMC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

An assesment of an optical system that measures blood pressure on the finger -Elfor 1 device. The system is based on a small optical sensor that emits coherent light into the skin and collects the reflected light from the red blood cells in the blood vessels in the skin under the sensor. The sensor is able to detect the pulse wave and blood pressure can be measured. The investigators plan to measure blood pressure with the new sensor in patients who are attending the Hypertension Clinic at Meir Hospital or are undergoing hemodialysis to validate the sensor.

Conditions

Blood Pressure Disorders

Outcome Measures

Primary Outcomes (1)

• Blood pressure reading

  Measurements will be performed with a standard plethysmograph and with a new sensor

  three hours

Study Arms (1)

Blood pressure measurement

EXPERIMENTAL

Patients requiring blood pressure measurement will have their blood pressure measured in the standard manner by plethysmography, and then with the Elfor -1 device , the new optical sensor, in order to determine the performance of the new sensor.

Device: Blood pressure measurement; Device: Blood pressure measurement with the new device

Interventions

Blood pressure measurement DEVICE

Blood pressure measurement with a standard plethysmograph

Blood pressure measurement

Blood pressure measurement with the new device DEVICE

Blood pressure measurement with the optical sensor, Elfor -1 device.

Blood pressure measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients on hemodialysis or visiting the hypertension outpatient clinic at Meir Medical Hospital.

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Interventions

Blood Pressure Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Invastigator

Model Details: Subjects will have their blood pressure measured by standard plethysmography and with a new optical device

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 3, 2017
• Study Start: February 15, 2017
• Primary Completion: February 15, 2018
• Study Completion: April 1, 2018
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share