Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments

NCT ID: NCT05435950

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-02
• Study Completion Date: 2023-03-10

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).

Conditions

Trigger Finger; Trigger Thumb; Carpal Tunnel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adult participants with Carpal Tunnel syndrome or with Trigger Finger/Thumb

Group Type: EXPERIMENTAL

Sono-Intruments

Intervention Type: DEVICE

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:

• The Carpal Tunnel Sono-Instrument® (CT-SI), for CT syndrome release, by progressively cutting the transverse carpal ligament.
• The Trigger Finger Sono-Instrument® (TF-SI), for TF release by progressively cutting the A1 annual pulley.

Interventions

Sono-Intruments

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:

• The Carpal Tunnel Sono-Instrument® (CT-SI), for CT syndrome release, by progressively cutting the transverse carpal ligament.
• The Trigger Finger Sono-Instrument® (TF-SI), for TF release by progressively cutting the A1 annual pulley.

Intervention Type: DEVICE

Eligibility Criteria

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:

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Archer Research

INDUSTRY

Sponsor Role: collaborator

Spirecut

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Erasme University Hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

SONO-01

Identifier Type: -

Identifier Source: org_study_id