Clinical trial NCT05435950: Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Finger
Trigger Thumb
Carpal Tunnel Syndrome
Lead sponsor: Spirecut
Sponsor class: INDUSTRY
Collaborators: name: Archer Research
First posted: 2022-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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 causing malalignment or distortion of the local skeleton due to trauma, arthritis or other causes;
* Other known clinical risks outweighing the expected clinical benefits or increasing the risk of a postoperative lesion (e.g. tissue adhesions, anatomical abnormalities, neuro-vascular structures in the zone of the intended release, local tumors);
* Insufficient sonographic identification of the operated tissue;
* Previous attempt to treat the condition;
* Currently receiving treatment for CT or TF;
* Contra-indication to local anesthesia (general, regional or local);
* Participant unable (vulnerable participant)/unwilling to provide informed consent;
* Participant is enrolled in another study.

Primary outcomes:
measure: Safety of percutaneous surgery performed with Sono-Instuments
timeFrame: During the index procedure
measure: Safety of percutaneous surgery performed with Sono-Instuments
timeFrame: Within 1 week after the procedure
measure: Safety of percutaneous surgery performed with Sono-Instuments
timeFrame: 6 weeks after the procedure
Secondary outcomes:
measure: Performance of Sono-Instruments during percutaneous surgery
timeFrame: During the index procedure
measure: Performance of Sono-Instruments during percutaneous surgery
timeFrame: During the index procedure
measure: Performance of Sono-Instruments during percutaneous surgery
timeFrame: During the index procedure
measure: Performance of Sono-Instruments during percutaneous surgery
timeFrame: During the index procedure
measure: Pre-operative pain
timeFrame: During screening
measure: Post-operative pain of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Post-operative pain of percutaneous surgery performed with Sono-Instruments
timeFrame: 6 weeks after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: During screening
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: During screening
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: During screening
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: During screening
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: During screening
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: During screening
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: During screening
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: 6 weeks after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: 6 weeks after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: 6 weeks after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: 6 weeks after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: 6 weeks after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: 6 weeks after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: 6 weeks after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: 6 weeks after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: Within 1 week after the procedure
measure: Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
timeFrame: 6 weeks after the procedure
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme University Hospital
Study officials:
References: