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

NCT05435950 | Completed

• 1 other identifier: SONO-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Trigger Finger; Trigger Thumb; Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (3)

• Safety of percutaneous surgery performed with Sono-Instuments

  Number of peri- and post-operative (serious) adverse events, including operative and post-operative complications (e.g. infection), symptomatic recurrences and re-interventions.

  During the index procedure

• Safety of percutaneous surgery performed with Sono-Instuments

  Number of peri- and post-operative (serious) adverse events, including operative and post-operative complications (e.g. infection), symptomatic recurrences and re-interventions.

  Within 1 week after the procedure

• Safety of percutaneous surgery performed with Sono-Instuments

  Number of peri- and post-operative (serious) adverse events, including operative and post-operative complications (e.g. infection), symptomatic recurrences and re-interventions.

  6 weeks after the procedure

Secondary Outcomes (35)

• Performance of Sono-Instruments during percutaneous surgery

  During the index procedure

• Performance of Sono-Instruments during percutaneous surgery

  During the index procedure

• Performance of Sono-Instruments during percutaneous surgery

  During the index procedure

• Performance of Sono-Instruments during percutaneous surgery

  During the index procedure

• Pre-operative pain

  During screening

Study Arms (1)

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

EXPERIMENTAL

Device: Sono-Intruments

Interventions

Sono-Intruments 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spirecut: lead
• Archer Research: collaborator

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Trigger Finger Disorder; Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 28, 2022
• Study Start: September 2, 2022
• Primary Completion: January 27, 2023
• Study Completion: March 10, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)