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Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06510062
Enrollment
67
Registered
2024-07-19
Start date
2024-07-22
Completion date
2024-12-31
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measurement of Circulation on Anatomical Locations of the Body

Brief summary

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Interventions

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.

Topical pain relief gel worn via SAM patch.

Sponsors

ZetrOZ, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Flow (Perfusion Unit)0 - 1 hourBlood Flow Flux through Upper Extremity (Perfusion Unit)
Ultrasound Diathermy (Degrees Centigrade)0 - 1 hourTemperature Measurement on Body (Degrees Centrigrade)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026