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| Name | Class |
|---|---|
| Archer Research | INDUSTRY |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult participants with Carpal Tunnel syndrome or with Trigger Finger/Thumb | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of Sono-Instruments during percutaneous surgery | Ease of positioning of Sono-Instruments during percutaneous surgery. A score ranging from 0 (very unsatisfied) to 4 (very satisfied) will be documented by surgeons experienced in performing percutaneous surgery. | During the index procedure |
| Performance of Sono-Instruments during percutaneous surgery |
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Participants with Carpal tunnel syndrome:
Inclusion Criteria:
Participants with Trigger Finger/thumb:
Inclusion Criteria:
Exclusion criteria:
Participants with one or more of the following conditions are excluded from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme University Hospital | Brussels | 1070 | Belgium |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 19, 2023 | |
| Reset | Feb 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2023 | Feb 16, 2024 |
| ID | Term |
|---|---|
| D052582 | Trigger Finger Disorder |
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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|
Maneuverability of Sono-Instruments during percutaneous surgery. A score ranging from 0 (very unsatisfied) to 4 (very satisfied) will be documented by surgeons experienced in performing percutaneous surgery. |
| During the index procedure |
| Performance of Sono-Instruments during percutaneous surgery | Visibility (location and orientation) of the Sono-Instruments under sonography. A score ranging from 0 (very unsatisfied) to 4 (very satisfied) will be documented by surgeons experienced in performing percutaneous surgery. | During the index procedure |
| Performance of Sono-Instruments during percutaneous surgery | Technical success of the surgical procedure, defined as percutaneous surgery as intended without technical difficulties and without conversion to another surgical intervention. | During the index procedure |
| Pre-operative pain | Pain is assessed using the Numeric pain Rating Scale (NRS) in rest and activity (e.g. use for light daily activities like eating with the operated hand, putting the clothes on, washing the hands etc.). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). | During screening |
| Post-operative pain of percutaneous surgery performed with Sono-Instruments | Pain is assessed using the Numeric pain Rating Scale (NRS) in rest and activity (e.g. use for light daily activities like eating with the operated hand, putting the clothes on, washing the hands etc.). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). | Within 1 week after the procedure |
| Post-operative pain of percutaneous surgery performed with Sono-Instruments | Pain is assessed using the Numeric pain Rating Scale (NRS) in rest and activity (e.g. use for light daily activities like eating with the operated hand, putting the clothes on, washing the hands etc.). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). | 6 weeks after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document use of anti-inflammatory/pain medications. | During screening |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document what the participant cannot do with his/her affected hand. | During screening |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, including 11 items with 5 response options each (1 = no problem with activity, 5 = activity is not possible). | During screening |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ-SS) in patients with carpal tunnel syndrome, including 11 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | During screening |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ-FS) in patients with carpal tunnel syndrome, including 8 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | During screening |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Noting of numbness/pain at night in patients with carpal tunnel syndrome. | During screening |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quinnell grading system in patients with trigger finger/thumb, including 2 items with 5 response options each (0 = normal movement of the digit, 4 = fixed deformity). | During screening |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document use of anti-inflammatory/pain medication. | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document use of anti-inflammatory/pain medication. | 6 weeks after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document what the participant cannot do with his/her affected hand. | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Document what the participant cannot do with his/her affected hand. | 6 weeks after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, including 11 items with 5 response options each (1 = no problem with activity, 5 = activity is not possible). | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, including 11 items with 5 response options each (1 = no problem with activity, 5 = activity is not possible). | 6 weeks after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Post-operative time to return to activities of daily living as prescribed by the doctor and effectively done by participant. | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Post-operative time to return to work as prescribed by the doctor and effective return to work for participants that are employed. | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Number of days between surgery and washing of the operated hand for the first time. | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ-SS) in patients with carpal tunnel syndrome, including 11 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ-SS) in patients with carpal tunnel syndrome, including 11 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | 6 weeks after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ-FS) in patients with carpal tunnel syndrome, including 8 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ-FS) in patients with carpal tunnel syndrome, including 8 items with 5 response options each (1 = low level of symptoms/difficulty, 5 = highly symptomatic/unable to complete functional tasks). | 6 weeks after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Noting of numbness/pain at night in patients with Carpal Tunnel Syndrome. | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Noting of numbness/pain at night in patients with Carpal Tunnel Syndrome. | 6 weeks after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Noting of pillar pain in patients with Carpal Tunnel Syndrome. | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Noting of pillar pain in patients with Carpal Tunnel Syndrome. | 6 weeks after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quinnell grading system in patients with trigger finger/thumb, including 2 items with 5 response options each (0 = normal movement of the digit, 4 = fixed deformity). | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Quinnell grading system in patients with trigger finger/thumb, including 2 items with 5 response options each (0 = normal movement of the digit, 4 = fixed deformity). | 6 weeks after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Modified Patel and Bassini's grading system in patients with trigger finger/thumb, including 2 items with 4 response options each (1 = no improvement, 4 = full improvement). | Within 1 week after the procedure |
| Clinical effectiveness of percutaneous surgery performed with Sono-Instruments | Modified Patel and Bassini's grading system in patients with trigger finger/thumb, including 2 items with 4 response options each (1 = no improvement, 4 = full improvement). | 6 weeks after the procedure |
| D020423 |
| Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |