Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Phase 1

Completed

• Conditions: Measurement of Circulation on Anatomical Locations of the Body
• Interventions: Device: Sustained Acoustic Medicine; Drug: 2.5% Diclofenac Patches

• Registration Number: NCT06510062
• Lead Sponsor: ZetrOZ, Inc.

Brief Summary

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Study Start: 2024-07-22
• Status Verified: 2024-08
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAM Ultrasound Device and Diclofenac Patch 1	Sustained Acoustic Medicine	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.
SAM Ultrasound Device and SAM Patch 1	Sustained Acoustic Medicine	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.
SAM Ultrasound Device and Diclofenac Patch 2	Sustained Acoustic Medicine	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.
SAM Ultrasound Device and SAM Patch 2	Sustained Acoustic Medicine	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.
SAM Ultrasound Device and Diclofenac Patch 1	Sustained Acoustic Medicine	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.
SAM Ultrasound Device and Diclofenac Patch 1	2.5% Diclofenac Patches	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.
SAM Ultrasound Device and Diclofenac Patch 2	Sustained Acoustic Medicine	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.
SAM Ultrasound Device and Diclofenac Patch 2	2.5% Diclofenac Patches	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.
SAM Ultrasound Device and SAM Patch 1	Sustained Acoustic Medicine	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.
SAM Ultrasound Device and SAM Patch 2	Sustained Acoustic Medicine	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.

Primary Outcome Measures

Name	Time	Method
Blood Flow (Perfusion Unit)	0 - 1 hour	Blood Flow Flux through Upper Extremity (Perfusion Unit)
Ultrasound Diathermy (Degrees Centigrade)	0 - 1 hour	Temperature Measurement on Body (Degrees Centrigrade)

Trial Locations

Locations (1)

ZetrOZ Systems LLC; 🇺🇸 Trumbull, Connecticut, United States