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Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT05435950•Spirecut

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with Carpal tunnel syndrome:
•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;
+5 more criteria

Locations (1)

Erasme University Hospital

Brussels, Belgium

Key Dates

Start Date

September 2, 2022

Primary Completion Date

January 27, 2023

Completion Date

March 10, 2023

Last Updated

May 18, 2023

Enrollment

ACTUAL participants

Conditions

Trigger FingerTrigger ThumbCarpal Tunnel Syndrome

Interventions

Sono-Intruments

DEVICE

Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger

NCT07256522

Trigger FingerSplint Therapy+4 more

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RECRUITINGNA

Comparison of Ultrasound-Guided Injection With Median Nerve Decompression Surgery in Carpal Tunnel Syndrome

NCT06243848

Musculoskeletal DiseasesMedian Nerve Disease+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger

Comparison of Ultrasound-Guided Injection With Median Nerve Decompression Surgery in Carpal Tunnel Syndrome

The Relationship Between Ultrasonographic Findings and Sleep Quality in Carpal Tunnel Syndrome

Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method

Evaluation by Clinical and Hand Ultrasound in Carpal Tunnel Syndrome

Small Nerve Fiber Activity in Patients with Carpal Tunnel Syndrome Assessed Via Quantitative Sensory Testing