Trigger FingerSONO-01NCT05435950
Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments
A study testing Sono-Intruments in people with Trigger Finger and Trigger Thumb, run by Spirecut at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger, Trigger Thumb, Carpal Tunnel Syndrome
- What is being tested?
- Sono-Intruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Sep 2022to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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:
- 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.
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
- Being tested
- Sono-Intruments
- Medical subject headings
- Trigger Finger Disorder, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sono-IntrumentsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult participants with Carpal Tunnel syndrome or with Trigger Finger/Thumb | Experimental | Not described Receives: Device: Sono-Intruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks after the procedure
Secondary outcomes (35)
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.
Measured: During the index procedure
Performance of Sono-Instruments during percutaneous surgery
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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document use of anti-inflammatory/pain medications.
Measured: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document what the participant cannot do with his/her affected hand.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Noting of numbness/pain at night in patients with carpal tunnel syndrome.
Measured: 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).
Measured: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document use of anti-inflammatory/pain medication.
Measured: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Document use of anti-inflammatory/pain medication.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Noting of pillar pain in patients with Carpal Tunnel Syndrome.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start2 Sep 2022
- Primary completion27 Jan 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spirecut
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435950
- Sponsor's protocol ID
- SONO-01
- Acronym
- SONO-01
- Status last verified
- May 2023
- First submitted
- 9 Jun 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05435950
- Acronym / sponsor ID
- SONO-01 / SONO-01
- Conditions
- Trigger Finger, Trigger Thumb, Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SpirecutIndustry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult participants with Carpal Tunnel syndrome or with Trigger Finger/Thumb | Experimental | Device: Sono-Intruments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Adults ≥ 18 years of age;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sono-IntrumentsSpirecut'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. | Device | Adult participants with Carpal Tunnel syndrome or with Trigger Finger/Thumb |
Primary outcome
Safety of percutaneous surgery performed with Sono-Instuments
Time frame: During the index procedure
Number of peri- and post-operative (serious) adverse events, including operative and post-operative complications (e.g. infection), symptomatic recurrences and re-interventions.
Safety of percutaneous surgery performed with Sono-Instuments
Time frame: Within 1 week after the procedure
Number of peri- and post-operative (serious) adverse events, including operative and post-operative complications (e.g. infection), symptomatic recurrences and re-interventions.
Safety of percutaneous surgery performed with Sono-Instuments
Time frame: 6 weeks after the procedure
Number of peri- and post-operative (serious) adverse events, including operative and post-operative complications (e.g. infection), symptomatic recurrences and re-interventions.
35 secondary outcomes
Performance of Sono-Instruments during percutaneous surgery
Time frame: During the index procedure
Performance of Sono-Instruments during percutaneous surgery
Time frame: During the index procedure
Performance of Sono-Instruments during percutaneous surgery
Time frame: During the index procedure
Performance of Sono-Instruments during percutaneous surgery
Time frame: During the index procedure
Pre-operative pain
Time frame: During screening
Post-operative pain of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Post-operative pain of percutaneous surgery performed with Sono-Instruments
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: During screening
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: 6 weeks after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: Within 1 week after the procedure
Clinical effectiveness of percutaneous surgery performed with Sono-Instruments
Time frame: 6 weeks after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sono-Intruments in people with Trigger Finger and Trigger Thumb, run by Spirecut at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of percutaneous surgery performed with Sono-Instuments (time frame: During the index procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.