Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT05435950
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05435950
Study Brief:
Protocol Section:
NCT05435950