Sonex Health is highlighting two-year results showing the safety and efficacy of ultrasound-guided carpal tunnel release (UGCTR) using the UltraGuideCTR device in an office-based setting.
Published in Plastic and Reconstructive Surgery – Global Online, the results from the Robust trial represent the longest and largest prospective evaluation of office-based UGCTR to date, Sonex said.
The prospective, multicenter, observational study enrolled 149 patients and 226 hands across seven U.S. centers, with all procedures performed using only local anesthesia in a clinic setting. More than 92% of patients completed two-year follow-up assessments, according to the researchers.
Key findings at two years include the following:
- Symptom improvement occurred rapidly within the first two weeks and was sustained through two years.
- Patients returned to activities and work at two and four days, respectively.
- Overall satisfaction was 95.7% at the two-year mark, the highest value recorded across the follow-up period.
- No revisions were required for persistent or recurrent carpal tunnel syndrome symptoms.
- 52% of patients underwent simultaneous bilateral procedures, which were similarly safe and effective as unilateral procedures.
The study was led by principal investigator Ashley Pistorio, MD, associate professor and plastic surgery residency program director at the University of Nevada, Las Vegas.
The Robust data add to a body of 21 peer-reviewed publications representing more than 2,200 patients and 2,800 hands supporting UGCTR, Sonex said.
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
