Measurement of Circulation on Anatomical Locations of the BodyPhase 1NCT06510062
Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
A Phase 1 study testing Sustained Acoustic Medicine and 2.5% Diclofenac Patches in people with Measurement of Circulation on Anatomical Locations of the Body, run by ZetrOZ, Inc. at 1 site in United States.
Trial summary
Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Measurement of Circulation on Anatomical Locations of the Body
- What is being tested?
- Sustained Acoustic Medicine and 2.5% Diclofenac Patches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2024to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteer
Who cannot join
- Is pregnant/nursing
- Has an active infection, open sores, or wounds in the treatment area
- Has any preexisting extremity circulation condition
Trial locations and contacts
1 site in 1 country.
About this study
Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
- Being tested
- Sustained Acoustic Medicine, 2.5% Diclofenac Patches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained Acoustic MedicineDevice
Also called SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device Wearable
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.
Sustained Acoustic MedicineDevice
Also called SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device Wearable
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.
Sustained Acoustic MedicineDevice
Also called SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device Wearable
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.
Sustained Acoustic MedicineDevice
Also called SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device Wearable
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.
2.5% Diclofenac PatchesDrug
Topical pain relief gel worn via SAM patch.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Sustained Acoustic Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Flow (Perfusion Unit)
Blood Flow Flux through Upper Extremity (Perfusion Unit)
Measured: 0 - 1 hour
Ultrasound Diathermy (Degrees Centigrade)
Temperature Measurement on Body (Degrees Centrigrade)
Measured: 0 - 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start22 Jul 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Measurement of Circulation on Anatomical Locations of the BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George K Lewis, PhD, Principal investigator, ZetrOZ Systems LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510062
- Sponsor's protocol ID
- CR-01-2024
- Status last verified
- Aug 2024
- First submitted
- 15 Jul 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40687068
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
- ClinicalTrials.gov ID
- NCT06510062
- Acronym / sponsor ID
- CR-01-2024
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAM Ultrasound Device and Diclofenac Patch 1 | Experimental | Device: Sustained Acoustic Medicine, Drug: 2.5% Diclofenac PatchesPatients 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. |
| SAM Ultrasound Device and Diclofenac Patch 2 | Experimental | Device: Sustained Acoustic Medicine, Drug: 2.5% Diclofenac PatchesPatients 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. |
| SAM Ultrasound Device and SAM Patch 1 | Experimental | Device: Sustained Acoustic MedicinePatients 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. |
| SAM Ultrasound Device and SAM Patch 2 | Experimental | Device: Sustained Acoustic MedicinePatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Volunteer
Key exclusion criteria (3 listed)
- Is pregnant/nursing
- Has an active infection, open sores, or wounds in the treatment area
- Has any preexisting extremity circulation condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained Acoustic MedicineAlso: SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device WearableThe 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 | SAM Ultrasound Device and Diclofenac Patch 1 |
| Sustained Acoustic MedicineAlso: SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device WearableThe 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 | SAM Ultrasound Device and Diclofenac Patch 2 |
| Sustained Acoustic MedicineAlso: SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device WearableThe 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 | SAM Ultrasound Device and SAM Patch 1 |
| Sustained Acoustic MedicineAlso: SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device WearableThe 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 | SAM Ultrasound Device and SAM Patch 2 |
| 2.5% Diclofenac PatchesTopical pain relief gel worn via SAM patch. | Drug | SAM Ultrasound Device and Diclofenac Patch 1, SAM Ultrasound Device and Diclofenac Patch 2 |
Primary outcome
Blood Flow (Perfusion Unit)
Time frame: 0 - 1 hour
Blood Flow Flux through Upper Extremity (Perfusion Unit)
Ultrasound Diathermy (Degrees Centigrade)
Time frame: 0 - 1 hour
Temperature Measurement on Body (Degrees Centrigrade)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 40687068Scanzuso 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George K Lewis, PhD principal investigator
ZetrOZ Systems LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sustained Acoustic Medicine and 2.5% Diclofenac Patches in people with Measurement of Circulation on Anatomical Locations of the Body, run by ZetrOZ, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Flow (Perfusion Unit) (time frame: 0 - 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.