Acoustic Medicine for Circulation

Overseen By Rajiv Mallipudi, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ZetrOZ, Inc.

Disqualifiers: Pregnancy, Active infection, Circulation condition

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

67 Participants Needed

Trial Summary

What is the purpose of this trial?

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Research Team

George K Lewis, PhD

Principal Investigator

ZetrOZ Systems LLC

Eligibility Criteria

This trial is for healthy volunteers who want to help test a device called Sustained Acoustic Medicine on blood circulation. People can't join if they have infections, open sores, or wounds where the device will be used, any issues with blood flow in their limbs, or if they are pregnant or nursing.

Inclusion Criteria

Healthy Volunteer

Exclusion Criteria

I have an infection or open wounds in the area that would be treated.

I have a circulation problem in my arms or legs.

Is pregnant/nursing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive treatment from the SAM Ultrasonic Diathermy Device for 1 hour with either a diclofenac or standard ultrasound gel patch on the forearm

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Sustained Acoustic Medicine Device

Trial Overview The study is looking at how well a Sustained Acoustic Medicine device works to improve circulation. Participants will use this non-invasive treatment and researchers will measure changes in their pulse to see its effectiveness.

Participant Groups

Group I: SAM Ultrasound Device and SAM Patch 2 Experimental Treatment 1 Intervention

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.

Group II: SAM Ultrasound Device and SAM Patch 1 Experimental Treatment 1 Intervention

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.

Group III: SAM Ultrasound Device and Diclofenac Patch 2 Experimental Treatment 2 Interventions

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.

Group IV: SAM Ultrasound Device and Diclofenac Patch 1 Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

ZetrOZ, Inc.

Lead Sponsor

Trials

17

Recruited

1,500+