NCT06510062

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: ZetrOZ, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Conditions

• Measurement of Circulation on Anatomical Locations of the Body

Interventions

Type	Name	Description
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.
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.
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.
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.
DRUG	2.5% Diclofenac Patches	Topical pain relief gel worn via SAM patch.

Timeline

• Start date: 2024-07-22
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2024-07-19
• Last updated: 2025-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study