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Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments — SONO-01  

Carpal Tunnel Syndrome Clinical Trial

Official title:
Prospective, Monocenter, Non-randomized Clinical Investigation Evaluating the Safety, Clinical Performance and Effectiveness of Sono-instruments for the Percutaneous Ultrasound-guided Treatment of Carpal Tunnel Syndrome and Trigger Finger

Clinical Trial Summary

Carpal Tunnel (CT) syndrome is a collection of characteristic symptoms and signs that occurs following compression of the median nerve within the CT. In Trigger Finger / trigger thumb (TF), one of the most common causes of hand pain and disability, the flexor tendon causes painful popping or snapping as the patient flexes and extends the digit. In case of failure of non-operative treatments, patients with CT syndrome or TF are operated. Clearly any improvement in surgical device design would be of great advantage to the patient and the surgeon. Spirecut's single use, pre-CE Sono-Instruments (SI) allow the percutaneous treatment of Carpal Tunnel (CT)syndrome and Trigger Finger/thumb (TF) under sonography (instead of open or endoscopic approach). Two models will be assessed in this clinical investigation: 1. The Carpal Tunnel Sono-Instrument® (CT-SI), for CT syndrome release, by progressively cutting the transverse carpal ligament. 2. The Trigger Finger Sono-Instrument® (TF-SI), for TF release by progressively cutting the A1 annual pulley. Using those SI, surgical procedures can be performed without endangering adjacent structures (e.g. median nerve and branches, ulnar pedicle, superficial carpal arch, digital pedicles, flexor tendons).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05435950
Study type Interventional
Source Spirecut
Contact
Status Completed
Phase N/A
Start date September 2, 2022
Completion date March 10, 2023
View Details
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