Ultrasound-Guided Surgery for Carpal Tunnel Syndrome

(ROBUST Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new ultrasound-guided surgery for individuals with carpal tunnel syndrome, a condition causing numbness or tingling in the hand. The procedure, called Ultrasound Guided Carpal Tunnel Release (CTR-US), may provide a less invasive option for those who haven't found relief from treatments like splints or injections. It suits individuals diagnosed with carpal tunnel syndrome who have tried other treatments without success. Participants must be willing to complete follow-up questionnaires over two years. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for carpal tunnel syndrome.

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 prior data suggests that this ultrasound-guided technique is safe for carpal tunnel syndrome?

Research shows that ultrasound-guided carpal tunnel release (CTR-US) is generally safe. Studies have found that this procedure effectively treats carpal tunnel syndrome and carries a risk level similar to traditional open surgery. In one study, patients experienced significant improvements lasting up to six years after the procedure. Another study found that this method led to fewer complications and quicker recovery compared to other techniques.

Overall, real-world data indicate that CTR-US is well-tolerated. While no treatment is without risk, evidence suggests that this procedure is a safe option for many people with carpal tunnel syndrome. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultrasound-guided surgery for carpal tunnel syndrome because it offers a less invasive approach compared to traditional open or endoscopic carpal tunnel release surgeries. By using the UltraGuideCTR device, this method allows surgeons to precisely target the affected area with the help of ultrasound imaging, potentially leading to less tissue damage and quicker recovery times. Unlike conventional methods that might require larger incisions, ultrasound guidance minimizes the size of incisions, which can reduce pain and scarring and speed up healing.

What evidence suggests that Ultrasound Guided Carpal Tunnel Release is effective for Carpal Tunnel Syndrome?

Research has shown that Ultrasound Guided Carpal Tunnel Release (CTR-US), performed in this trial using the UltraGuideCTR device, safely and effectively treats carpal tunnel syndrome. People who underwent this procedure experienced significant improvements lasting up to six years. CTR-US carries risks similar to traditional open surgery, making it a reliable alternative. The UltraGuideCTR device has received high ratings for enhancing patients' hand function. Overall, strong evidence supports CTR-US as a good option for treating carpal tunnel syndrome. ^{4 5 6 7 8}

Who Is on the Research Team?

Ashley Pistorio, MD

Principal Investigator

University of Nevada, Las Vegas

Are You a Good Fit for This Trial?

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.

Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound

Exclusion Criteria

Pregnant or planning pregnancy in the next 24 months

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11133916/

Clinical Results of Carpal Tunnel Release Using Ultrasound ... CTR-US is a safe and effective procedure that results in significant improvements that persist up to 6 years postprocedure.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589514124000720

Carpal Tunnel Release with Ultrasound Guidance Versus ... Based on the available evidence, CTR-US is a safe and effective surgical option for treating carpal tunnel syndrome with a similar risk profile to open CTR.

3. sonexhealth.com sonexhealth.com/sonex-health-announces-ecri-favorable-rating/

ECRI Issues Evidence Bar "Favorable" Rating for ... Evidence Bar “Favorable” rating from ECRI report indicates UltraGuideCTR is safe and improves functional status in patients with carpal tunnel syndrome.

4. mdpi.com mdpi.com/2077-0383/13/1/262

Long-Term Outcomes of Ultrasound-Guided Thread Carpal ... Ultrasound-guided thread carpal tunnel release (TCTR) was proposed as an effective and safe surgical technique with faster recovery and fewer complications.

5. jhsgo.org jhsgo.org/article/S2589-5141(24)00127-0/fulltext

A Cost-Utility Analysis of Carpal Tunnel Release With ... The objective of this study was to perform a cost-utility analysis comparing open carpal tunnel release (OCTR), endoscopic carpal tunnel ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40367647/

Real-world data on efficacy and safety of 1256 consecutive ... This study evaluated the efficacy and safety of ultrasound-guided carpal tunnel release (UCTR) in routine clinical practice. Furthermore, we ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681525002712

Real-world data on efficacy and safety of 1256 consecutive ... This study evaluated the efficacy and safety of ultrasound-guided carpal tunnel release (UCTR) in routine clinical practice. Furthermore, we assessed UCTR ...

8. jhsgo.org jhsgo.org/article/S2589-5141(24)00072-0/fulltext

Carpal Tunnel Release with Ultrasound Guidance Versus ... Based on the available evidence, CTR-US is a safe and effective surgical option for treating carpal tunnel syndrome with a similar risk profile to open CTR.