Acoustic Medicine for Circulation
RM
Overseen ByRajiv Mallipudi, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: ZetrOZ, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
Research Team
GK
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
4Treatment groups
Experimental Treatment
Group I: SAM Ultrasound Device and SAM Patch 2Experimental Treatment1 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 1Experimental Treatment1 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 2Experimental Treatment2 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 1Experimental Treatment2 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ZetrOZ, Inc.
Lead Sponsor
Trials
17
Recruited
1,500+
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