Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Study Overview

• Status: Completed
• Conditions: Measurement of Circulation on Anatomical Locations of the Body
• Intervention / Treatment: Device: Sustained Acoustic Medicine; Drug: 2.5% Diclofenac Patches

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Trumbull, Connecticut, United States, 06611
      • ZetrOZ Systems LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAM Ultrasound Device and Diclofenac Patch 1; 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.	Device: Sustained Acoustic Medicine; The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.; Other Names: SAM; Wearable Ultrasound Device; Long Duration Ultrasound; Long Duration Low-Intensity Device; LITUS Device Wearable; Drug: 2.5% Diclofenac Patches; Topical pain relief gel worn via SAM patch.
Experimental: SAM Ultrasound Device and Diclofenac Patch 2; 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.	Device: Sustained Acoustic Medicine; The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.; Other Names: SAM; Wearable Ultrasound Device; Long Duration Ultrasound; Long Duration Low-Intensity Device; LITUS Device Wearable; Drug: 2.5% Diclofenac Patches; Topical pain relief gel worn via SAM patch.
Experimental: SAM Ultrasound Device and SAM Patch 1; 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.	Device: Sustained Acoustic Medicine; The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.; Other Names: SAM; Wearable Ultrasound Device; Long Duration Ultrasound; Long Duration Low-Intensity Device; LITUS Device Wearable
Experimental: SAM Ultrasound Device and SAM Patch 2; 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.	Device: Sustained Acoustic Medicine; The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.; Other Names: SAM; Wearable Ultrasound Device; Long Duration Ultrasound; Long Duration Low-Intensity Device; LITUS Device Wearable

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ZetrOZ, Inc.
• Investigators: Principal Investigator: George K Lewis, PhD, ZetrOZ Systems LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: CR-01-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No