Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments (NCT05435950) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments
Belgium30 participantsStarted 2022-09-02
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Participants with Carpal tunnel syndrome:
Inclusion Criteria:
* Adults ≥ 18 years of age;
* Primary CT confirmed by typical symptoms, signs and altered nerve conduction studies;
* Pain and/or numbness in the hand which worsen at night (or are present only at night);
* Participant and investigator signed and dated the Informed Consent Form (ICF) prior to the index-procedure.
Participants with Trigger Finger/thumb:
Inclusion Criteria:
* Adults ≥ 18 years of age;
* Typical signs and symptoms of TF/thumb caused by friction or blockade of flexor tendon(s) in digital sheath, without flexion contracture over 30° of the proximal interphalangeal (or interphalangeal for the thumb) joint, confirmed by altered flexor tendon(s) gliding and/or increased thickness of A1 digital pulley under sonography (sonography can be done just before the operation, that is after signature of the ICF);
* Participant and investigator signed and dated the ICF prior to the index-procedure.
Exclusion criteria:
Participants with one or more of the following conditions are excluded from the study:
* Dwarfism or participants with small size hand/CT/TF-thumb;
* Past or active infection;
* Known allergic reaction to metals;
* Coagulation problems, with significant risk of per/postoperative bleeding;
* In case of TF: long evolution, with ankylosis of the proximal interphalangeal joint;
* In case of CT: severe median nerve dysfunction;
* Previous facture or dislocation in the operated area or any affection c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of percutaneous surgery performed with Sono-Instuments
Timeframe: During the index procedure
2
Safety of percutaneous surgery performed with Sono-Instuments
Timeframe: Within 1 week after the procedure
3
Safety of percutaneous surgery performed with Sono-Instuments