Clinical Trials Logo
  1. Home
  2. Carpal Tunnel Syndrome
  3. NCT05435950

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
See also
  Status Clinical Trial Phase
Completed NCT05067205 - Minimal Invasive Carpal Tunnel Release With the Novel Device N/A
Completed NCT03184688 - Platelet Rich Plasma for Carpal Tunnel Syndrome N/A
Completed NCT03582735 - Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome N/A
Completed NCT05490420 - Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome N/A
Recruiting NCT05970692 - Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
Completed NCT04043780 - Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome N/A
Completed NCT03880812 - Cost Information on Carpal Tunnel Syndrome Treatment Decisions N/A
Completed NCT06464809 - Treatment Intervention of Patients With Carpal Tunnel Syndrome (CTS) N/A
Recruiting NCT05328180 - aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE) N/A
Recruiting NCT05503719 - An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial N/A
Recruiting NCT05372393 - Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block N/A
Recruiting NCT05466162 - Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome N/A
Completed NCT04060875 - Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Not yet recruiting NCT06294821 - 4AP to Delay Carpal Tunnel Release (CTR) Phase 2/Phase 3
Not yet recruiting NCT04328805 - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome. Phase 4
Terminated NCT02791529 - Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release Phase 1
Completed NCT02141035 - Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome Phase 2/Phase 3
Completed NCT01887145 - Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome N/A
Recruiting NCT01897272 - Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study N/A
Completed NCT01394822 - Neuromuscular Ultrasound for Focal Neuropathies N/A