Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590610
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Post-Market Clinical Follow-up HVS on Increased Circulation RPW2 and Cefar TENS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Independent Temporary Effects of Intelect RPW2 Radial Pressure Wave and Cefar TENS NMES Treatments on the Local Circuclation of Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a prospective single-center open-label post-market investigational study on healthy volunteers conducted in the United Kingdom
Sponsor is conducting this prospective study to collect PMCF data on the safety and performance of Intelect RPW2 and CEFAR TENS devices in accordance with Medical Device Regulation EU 2017745 MDR Article 61 and Part B of Annex XIV
The aim of this study is to measure the hemodynamic changes in the lower limb consequent to the use of CEFAR TENS via neuromuscular electrical stimulation NMES and to the use of Intelect RPW2 via radial pressure waves RPW
The hypothesis of this study is that the application of both medical devices CEFAR TENS or Intelect RPW2 to the calf muscles will increase venous return as a local and temporary effect of the treatment
The hemodynamic measurements will be recorded with a Duplex ultrasound at baseline before the treatment as steady state condition during the treatment session at several timepoints and after each treatments end
Sponsor is conducting this prospective study to collect PMCF data on the safety and performance of Intelect RPW2 and CEFAR TENS devices in accordance with Medical Device Regulation EU 2017745 MDR Article 61 and Part B of Annex XIV
The aim of this study is to measure the hemodynamic changes in the lower limb consequent to the use of CEFAR TENS via neuromuscular electrical stimulation NMES and to the use of Intelect RPW2 via radial pressure waves RPW
The hypothesis of this study is that the application of both medical devices CEFAR TENS or Intelect RPW2 to the calf muscles will increase venous return as a local and temporary effect of the treatment
The hemodynamic measurements will be recorded with a Duplex ultrasound at baseline before the treatment as steady state condition during the treatment session at several timepoints and after each treatments end
Detailed Description:
The selected 20 healthy subjects will undergo one treatment per device for both electrostimulation and radial pressure wave therapy on both the right and left Gastrocnemius device placement on each leg will be randomized prior to application with each device having an equal chance of being placed on the either leg dominant and non-dominant Each subject will receive treatment via the Intelect RPW2 device to either the right or left leg and afterwards the subject will receive treatment via the CEFAR TENS device to the opposite leg as per the randomization table
The capability of the radial pressure waves therapy Intelect RPW2 and NMES CEFAR TENS to improve local and temporarily hemodynamics on the treated limb will be investigated
The subject will firstly receive RPW treatment and secondly receive NMES treatment this will be consistent for all subjects as an arbitrary decision to be consistent throughout the whole study with the treatments application
Subjects will be positioned in the prone decubitus position for a minimum of 3 minutes or until the steady state condition is reached automated blood pressure cuff will be used to record blood pressure and pulse from upper arm Following the rest period the measurement by means of a Duplex Ultrasound will be performed Peak venous velocity Ejected volume Time averaged Mean venous velocity and Volume flow will be recorded in the leg to be treated with RPW Subjects will remain in this position for the duration of the treatment corresponding to 2 minutes and 30 seconds by RPW and 10 minutes for NMES the study staff will apply the Intelect RPW2 device to either the right or left leg according to the randomization plan During the RPW treatment the hemodynamic parameters in the subject leg will be measured at 30 seconds 1 minute 1 minute and 30 seconds 2 minutes and 2 minutes and 30 seconds after RPW treatment is started and at 1 2 5 and 10 minutes after RPW treatment end Arterial blood pressure and heart rate measurement will be recorded after RPW treatment end from upper arm
Then the study staff will apply the CEFAR TENS device to the opposite leg During the NMES treatment the hemodynamic parameters in the subject leg will be measured at 30 seconds 1 2 5 8 and 10 minutes after NMES treatment is started and at 1 2 5 and 10 minutes after treatments end Blood pressure and pulse will be recorded after NMES treatment end from upper arm
The treatment with Intelect RPW2 and CEFAR TENS devices will be performed by the study staff after training on the devices use
A Vascular Technologist will perform the hemodynamic measurements by Duplex Ultrasound device
A virtual follow up visit will be scheduled one week following treatment
The capability of the radial pressure waves therapy Intelect RPW2 and NMES CEFAR TENS to improve local and temporarily hemodynamics on the treated limb will be investigated
The subject will firstly receive RPW treatment and secondly receive NMES treatment this will be consistent for all subjects as an arbitrary decision to be consistent throughout the whole study with the treatments application
Subjects will be positioned in the prone decubitus position for a minimum of 3 minutes or until the steady state condition is reached automated blood pressure cuff will be used to record blood pressure and pulse from upper arm Following the rest period the measurement by means of a Duplex Ultrasound will be performed Peak venous velocity Ejected volume Time averaged Mean venous velocity and Volume flow will be recorded in the leg to be treated with RPW Subjects will remain in this position for the duration of the treatment corresponding to 2 minutes and 30 seconds by RPW and 10 minutes for NMES the study staff will apply the Intelect RPW2 device to either the right or left leg according to the randomization plan During the RPW treatment the hemodynamic parameters in the subject leg will be measured at 30 seconds 1 minute 1 minute and 30 seconds 2 minutes and 2 minutes and 30 seconds after RPW treatment is started and at 1 2 5 and 10 minutes after RPW treatment end Arterial blood pressure and heart rate measurement will be recorded after RPW treatment end from upper arm
Then the study staff will apply the CEFAR TENS device to the opposite leg During the NMES treatment the hemodynamic parameters in the subject leg will be measured at 30 seconds 1 2 5 8 and 10 minutes after NMES treatment is started and at 1 2 5 and 10 minutes after treatments end Blood pressure and pulse will be recorded after NMES treatment end from upper arm
The treatment with Intelect RPW2 and CEFAR TENS devices will be performed by the study staff after training on the devices use
A Vascular Technologist will perform the hemodynamic measurements by Duplex Ultrasound device
A virtual follow up visit will be scheduled one week following treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None