Ultrasound-Guided Surgery for Carpal Tunnel Syndrome

(ROBUST Trial)

Recruiting at 8 trial locations

Overseen By Amanda Maltzen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonex Health, Inc.

Must not be taking: Corticosteroids

Disqualifiers: Degenerative arthritis, Inflammatory disease, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

149 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have diabetes, it must be controlled by a stable dose of medication, and corticosteroid injections in the target hand are not allowed within 6 weeks of the procedure.

What data supports the effectiveness of the treatment Ultrasound Guided Carpal Tunnel Release (CTR-US)?

Research shows that using ultrasound guidance for carpal tunnel release is effective and safe, with studies reporting positive outcomes in routine clinical practice and community settings. It is also noted to be minimally invasive, which can lead to quicker recovery compared to traditional open surgery. ^{1 2 3 4 5}

Is ultrasound-guided surgery for carpal tunnel syndrome safe for humans?

Ultrasound-guided procedures are generally safe for humans, with most side effects being mild and temporary, such as tenderness or redness. Serious adverse reactions are rare, and any side effects usually resolve on their own. ^{6 7 8 9 10}

How is ultrasound-guided carpal tunnel release different from other treatments for carpal tunnel syndrome?

Ultrasound-guided carpal tunnel release (CTR-US) is a minimally invasive procedure that uses ultrasound to guide the surgical tools, allowing for precise cutting of the transverse carpal ligament with less tissue damage. This approach typically results in less pain, quicker recovery, and fewer complications compared to traditional open surgery. ^{1 2 4 5 11}

What is the purpose of this trial?

Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting.

Research Team

Ashley Pistorio, MD

Principal Investigator

University of Nevada, Las Vegas

Eligibility Criteria

This trial is for adults over 18 with Carpal Tunnel Syndrome (CTS) who've tried non-surgical treatments without success. They must have a CTS-6 score above 12, a median nerve area of at least 10 mm2 in the affected hand, and be able to complete surveys for two years using a smartphone or email. Exclusions include prior surgery on the wrist/hand (except minor procedures), infections, other conditions needing intervention, uncontrolled thyroid disease, pregnancy plans within two years, and inability to consent.

Inclusion Criteria

CTS-6 score >12 in target hand

I have been diagnosed with carpal tunnel syndrome in one or both hands.

Subject agrees to complete follow-up questionnaires over a 24-month period

Exclusion Criteria

Pregnant or planning pregnancy in the next 24 months

Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements

I have had carpal tunnel release surgery on the hand in question.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events, satisfaction, quality of life, pain, and functional status

3 months

Multiple assessments over 3 months

Treatment Details

Interventions

• Ultrasound Guided Carpal Tunnel Release (CTR-US)

Trial Overview The ROBUST trial tests an office-based procedure called Ultrasound Guided Carpal Tunnel Release (CTR-US) on patients with symptomatic CTS. It's a single-arm study meaning all participants receive the same treatment without comparison to another group or placebo.

Participant Groups

Group I: Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device Experimental Treatment 1 Intervention

Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study.

Who Is Running the Clinical Trial?

Sonex Health, Inc.

Lead Sponsor

Trials

4

Recruited

2,700+

Findings from Research

In a study involving 750 dogs and cats, contrast-enhanced ultrasonography (CEUS) was found to be safe, with only 3 immediate adverse events and 1 delayed event reported in dogs, and no adverse events in cats.

The risk of death within 24 hours after ultrasonography was similar for animals that underwent CEUS and those that had standard ultrasonography without contrast, indicating that CEUS does not increase mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of contrast-enhanced ultrasonography in dogs and cats: 488 cases (2002-2011). Seiler, GS., Brown, JC., Reetz, JA., et al.[2013]

Ultrasound contrast agents are generally safe for clinical use, with serious adverse reactions being rare and most adverse events being minor and self-resolving, such as headache and nausea.

The Contrast Media Safety Committee found that while intolerance to some components can occur, generalized allergy-like reactions are infrequent, emphasizing the overall well-tolerated nature of these agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents. Jakobsen, JA., Oyen, R., Thomsen, HS., et al.[2020]

Microfocused Ultrasound with Visualization (MFU-V) has a well-established safety profile, showing only mild and transient side effects like tenderness and redness, with rare adverse events typically linked to improper technique.

When used correctly, MFU-V treatments are safe, with most side effects resolving quickly and without lasting effects, indicating its efficacy in cosmetic dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. Hitchcock, TM., Dobke, MK.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided carpal tunnel release using the manos CTR system. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Minimally invasive ultrasound-guided vs open release for carpal tunnel syndrome in working population: A randomized controlled trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Office-Based Carpal Tunnel Release Using Ultrasound Guidance in a Community Setting: Long-Term Results. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Multicenter pragmatic study of carpal tunnel release with ultrasound guidance. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Minimal Invasive Carpal Tunnel Release: An Optimized Algorithm. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Application of CTU-Assisted Doppler Ultrasound Puncture in Nontube Percutaneous Nephrolithotomy, Its Effect on Patients' Complications, and Its Clinical Value. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Percutaneous nephrolithotomy guided solely by ultrasonography: a 5-year study of >700 cases. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of contrast-enhanced ultrasonography in dogs and cats: 488 cases (2002-2011). [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. [2022]

11. Denmark pubmed.ncbi.nlm.nih.gov

Implementation of ultrasound-guided carpal tunnel release. [2023]