NCT05435950

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Spirecut · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Trigger Finger
• Trigger Thumb
• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
DEVICE	Sono-Intruments	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: * The Carpal Tunnel Sono-Instrument® (CT-SI), for CT syndrome release, by progressively cutting the transverse carpal ligament. * The Trigger Finger Sono-Instrument® (TF-SI), for TF release by progressively cutting the A1 annual pulley.

Timeline

• Start date: 2022-09-02
• Primary completion: 2023-01-27
• Completion: 2023-03-10
• First posted: 2022-06-28
• Last updated: 2023-05-18

Locations

1 site across 1 country: Belgium