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NCT05883241 · ClinicalTrials.gov registry record · Phase 1
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
A Phase 1 study of Bone Fracture and Fresh Fracture, sponsored by ZetrOZ.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT05883241: Recruiting Phase 1 study of Bone Fracture and Fresh Fracture, sponsored by ZetrOZ.
NCT05883241 is a Phase 1 study of Bone Fracture and Fresh Fracture that is actively recruiting participants, run by ZetrOZ. The registered enrollment target is 90 participants, below the 66,785-participant average among 3 other Bone Fracture trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05883241, a Phase 1 study of Bone Fracture and Fresh Fracture, is actively recruiting participants, sponsored by ZetrOZ.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 2
- Study locations
Study 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. Secondary objectives are to assess the ability of LITUS to improve patients return to work time.
Primary Outcome
Change in the self-described pain units on a scale by patient at baseline and post-treatment.
Conditions Studied
Interventions
- DEVICE Sustained Acoustic Device with 2.5% Diclofenac Patch
- DRUG 2.5% Diclofenac Patches
Study Locations (2)
Connecticut
- ZetrOZ Systems LLC - Trumbull
Virginia
- National Sports Medicine Institute - Lansdowne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 1 |
What NCT05883241 shows while recruiting
NCT05883241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 66,785-participant average among 3 other Bone Fracture trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Bone Fracture appearing as the primary indexed condition, and to 2 interventions - of which Sustained Acoustic Device with 2.5% Diclofenac Patch is the first listed.
NCT05883241 reports a single indexed study location in Connecticut, Virginia.
Frequently Asked Questions
What is clinical trial NCT05883241 about?
NCT05883241 is a clinical study titled "Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture". 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 p...
What is the current status of trial NCT05883241?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2023-06-01. Estimated completion is 2026-02-28.
What conditions does trial NCT05883241 study?
This clinical trial studies the following conditions: Bone Fracture, Fresh Fracture.
What interventions are being tested in trial NCT05883241?
The interventions under investigation include: Sustained Acoustic Device with 2.5% Diclofenac Patch (DEVICE), 2.5% Diclofenac Patches (DRUG).
Who is sponsoring clinical trial NCT05883241?
This trial is sponsored by ZetrOZ, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05883241 being conducted?
This trial has 2 study locations across Connecticut, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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