Bone FracturePhase 1NCT05883241
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
A Phase 1 study testing Sustained Acoustic Device with 2.5% Diclofenac Patch and 2.5% Diclofenac Patches in people with Bone Fracture and Fresh Fracture, run by ZetrOZ, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Fracture, Fresh Fracture
- What is being tested?
- Sustained Acoustic Device with 2.5% Diclofenac Patch and 2.5% Diclofenac Patches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2023to 28 Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have physician-diagnosed bone fracture
- Are between 18-80 years of age
- Report a pain score between 3-7 (range: 0-10) prior to enrolment
- Report that pain from fracture negatively affects quality of life
- Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study
- Are deemed appropriate by their physician or by the study site physician to participate.
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- Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.
- Not use or initiate opioid and/or non-opioid analgesic medications.
- Be willing to discontinue any other interventional treatment modalities on the affected area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).
Who cannot join
- Cannot successfully demonstrate the ability to put on and take off the device.
- Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
- Is pregnant.
- Is a prisoner.
- Is non-ambulatory (unable to walk).
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- Has a pacemaker.
- Has a malignancy in the treatment area.
- Has an active infection, open sores, or wounds in the treatment area.
- Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.
- Has a known neuropathy (disease of the brain or spinal nerves).
- Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
- Are currently taking steroids.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
National Sports Medicine Institute
Lansdowne, Virginia, 20176
Timothy Johnson, MD, 7037295010, tjohnson@nationalsportsmed.com
- Recruiting
ZetrOZ Systems LLC
Trumbull, Connecticut, 06611
George K. Lewis, Ph.D., 18882029831, george@zetroz.com
About this study
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period.
The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain.
Secondary objectives are to assess the ability of LITUS to improve patients return to work time.
Read the detailed description
This is a 12-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from pain related to a bone fracture(s). The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 12 weeks, patients will self-apply their treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device, during treatment, and at the completion of treatment.
Over 90 subjects will be recruited from neighboring communities to the study site(s). The study is designed to reach a diverse target patient population.
- Conditions
- Bone Fracture, Fresh Fracture
- Being tested
- Sustained Acoustic Device with 2.5% Diclofenac Patch, 2.5% Diclofenac Patches
- Keywords
- Low-Intensity Ultrasound, Drug Delivery, Sonophoresis, Transdermal Drug Delivery, Non-Steroidal Anti-Inflammatory Drugs, Sustained Acoustic Medication, Low-Intensity Continuous Ultrasound
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained Acoustic Device with 2.5% Diclofenac PatchDevice
Also called ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device Wearable
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3-megahertz (MHz) frequency and 0.132 Watts/cm^2 with 2.5% Diclofenac patches.
2.5% Diclofenac PatchesDrug
Topical pain relief-gel worn during treatment via SAM patch.
| Study group | Role | What they receive |
|---|---|---|
| SAM Ultrasound Device and Diclofenac Patch | Experimental | Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm^2 intensity. Receives: Device: Sustained Acoustic Device with 2.5% Diclofenac Patch; Drug: 2.5% Diclofenac Patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline
Change in the self-described pain units on a scale by patient at baseline and post-treatment.
Measured: Through study completion, average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jun 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George K. Lewis, Ph.D., Principal investigator, ZetrOZ Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883241
- Sponsor's protocol ID
- BF-01-2023
- Status last verified
- Feb 2025
- First submitted
- 20 May 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
- ClinicalTrials.gov ID
- NCT05883241
- Acronym / sponsor ID
- BF-01-2023
- Conditions
- Bone Fracture, Fresh Fracture
- Keywords
- Low-Intensity Ultrasound, Drug Delivery, Sonophoresis, Transdermal Drug Delivery, Non-Steroidal Anti-Inflammatory Drugs, Sustained Acoustic Medication, Low-Intensity Continuous Ultrasound
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 31 May 2023 (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.
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period.
The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain.
Secondary objectives are to assess the ability of LITUS to improve patients return to work time.
Detailed description
This is a 12-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from pain related to a bone fracture(s). The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 12 weeks, patients will self-apply their treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device, during treatment, and at the completion of treatment.
Over 90 subjects will be recruited from neighboring communities to the study site(s). The study is designed to reach a diverse target patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAM Ultrasound Device and Diclofenac Patch | Experimental | Device: Sustained Acoustic Device with 2.5% Diclofenac Patch, Drug: 2.5% Diclofenac PatchesPatients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm^2 intensity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have physician-diagnosed bone fracture
- Are between 18-80 years of age
- Report a pain score between 3-7 (range: 0-10) prior to enrolment
- Report that pain from fracture negatively affects quality of life
- Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study
Key exclusion criteria (13 listed)
- Cannot successfully demonstrate the ability to put on and take off the device.
- Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
- Is pregnant.
- Is a prisoner.
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 Device with 2.5% Diclofenac PatchAlso: ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device WearablePatients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3-megahertz (MHz) frequency and 0.132 Watts/cm^2 with 2.5% Diclofenac patches. | Device | SAM Ultrasound Device and Diclofenac Patch |
| 2.5% Diclofenac PatchesTopical pain relief-gel worn during treatment via SAM patch. | Drug | SAM Ultrasound Device and Diclofenac Patch |
Primary outcome
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline
Time frame: Through study completion, average of 12 weeks.
Change in the self-described pain units on a scale by patient at baseline and post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Class II Medical DeviceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
George K. Lewis, Ph.D. principal investigator
ZetrOZ Systems
2 sites 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 Device with 2.5% Diclofenac Patch and 2.5% Diclofenac Patches in people with Bone Fracture and Fresh Fracture, run by ZetrOZ, Inc. at 2 sites 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George K. Lewis, Ph.D. (8882029831, george@zetroz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline (time frame: Through study completion, average of 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.