A Phase 1 interventional study of Sustained Acoustic Device with 2.5% Diclofenac Patch and 2.5% Diclofenac Patches in Bone Fracture and Fresh Fracture, sponsored by ZetrOZ, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by ZetrOZ, Inc. · Phase 1, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 90 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →ZetrOZ, Inc. is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Sustained Acoustic Device with 2.5% Diclofenac Patch · Drug: 2.5% Diclofenac Patches
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.
Also known as: ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device Wearable, Long Duration Low-Intensity Device
Topical pain relief-gel worn during treatment via SAM patch.
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.
Time frame: Through study completion, average of 12 weeks.
Plan to share: No
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ZetrOZ, Inc.