Status:
COMPLETED
Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments
Lead Sponsor:
Spirecut
Collaborating Sponsors:
Archer Research
Conditions:
Trigger Finger
Trigger Thumb
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05435950
Start Date
September 2 2022
End Date
March 10 2023
Last Update
May 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Erasme University Hospital
Brussels, Belgium, 1070