Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

NCT06510062 | Completed Phase 1 FDA Device

• 1 other identifier: CR-01-2024
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Conditions

Measurement of Circulation on Anatomical Locations of the Body

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

SAM Ultrasound Device and Diclofenac Patch 1

EXPERIMENTAL

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; Drug: 2.5% Diclofenac Patches

SAM Ultrasound Device and Diclofenac Patch 2

EXPERIMENTAL

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; Drug: 2.5% Diclofenac Patches

SAM Ultrasound Device and SAM Patch 1

EXPERIMENTAL

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

SAM Ultrasound Device and SAM Patch 2

EXPERIMENTAL

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

Interventions

Sustained Acoustic Medicine DEVICE

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.

Also known as: SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device Wearable, Long Duration Low-Intensity Device

SAM Ultrasound Device and Diclofenac Patch 1

2.5% Diclofenac Patches DRUG

Topical pain relief gel worn via SAM patch.

SAM Ultrasound Device and Diclofenac Patch 1; SAM Ultrasound Device and Diclofenac Patch 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Volunteer

You may not qualify if:

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

Sponsors & Collaborators

• ZetrOZ, Inc.: lead

Study Sites (1)

ZetrOZ Systems LLC

Trumbull, Connecticut, 06611, United States

Location

Related Publications (1)

• Scanzuso A, Hendren T, Egmont M, Zarkar J, Roberge M. Sustained acoustic medicine increases local circulation with a diclofenac delivery patch: a randomized placebo controlled study. Front Med Technol. 2025 Jul 4;7:1552294. doi: 10.3389/fmedt.2025.1552294. eCollection 2025.

  PMID: 40687068 DERIVED

Study Officials

• George K Lewis, PhD

  ZetrOZ Systems LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: July 22, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)