Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

ZetrOZ

Status and phase: Completed; Phase 1

Conditions: Measurement of Circulation on Anatomical Locations of the Body

Treatments: Device: Sustained Acoustic Medicine; Drug: 2.5% Diclofenac Patches

Study type: Interventional

Funder types: Industry

Identifiers

NCT06510062

CR-01-2024

Details and patient eligibility

About

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Enrollment: 67 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Volunteer

Exclusion criteria

• Is pregnant/nursing
• Has an active infection, open sores, or wounds in the treatment area
• Has any preexisting extremity circulation condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 4 patient groups

SAM Ultrasound Device and Diclofenac Patch 1

Experimental group

Description:

Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with 2.5% diclofenac ultrasound gel patch on right forearm. The SAM device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Treatment:

Device: Sustained Acoustic Medicine

Drug: 2.5% Diclofenac Patches

Device: Sustained Acoustic Medicine

Device: Sustained Acoustic Medicine

Device: Sustained Acoustic Medicine

SAM Ultrasound Device and Diclofenac Patch 2

Experimental group

Description:

Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with 2.5% diclofenac ultrasound gel patch on left forearm. The SAM device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Treatment:

Device: Sustained Acoustic Medicine

Drug: 2.5% Diclofenac Patches

Device: Sustained Acoustic Medicine

Device: Sustained Acoustic Medicine

Device: Sustained Acoustic Medicine

SAM Ultrasound Device and SAM Patch 1

Experimental group

Description:

Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with standard ultrasound gel patch on right forearm. The SAM device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Treatment:

Device: Sustained Acoustic Medicine

Device: Sustained Acoustic Medicine

Device: Sustained Acoustic Medicine

Device: Sustained Acoustic Medicine

SAM Ultrasound Device and SAM Patch 2

Experimental group

Description:

Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with standard ultrasound gel patch on left forearm. The SAM device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Treatment:

Device: Sustained Acoustic Medicine

Device: Sustained Acoustic Medicine

Device: Sustained Acoustic Medicine

Device: Sustained Acoustic Medicine