Nerve InjuryREGENNCT07084207
A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair
A study testing Symani® Surgical System and Manual Surgery in people with Nerve Injury and Peripheral Nerve Injuries, run by MMI (Medical Microinstruments, Inc.) at 1 site in Germany.
Trial summary
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical nerve coaptation, following nerve injuries to the hand. This study will include participants with traumatic sensory nerve lesions of a finger nerve distal to the carpal tunnel who are treated with nerve suturing. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nerve Injury, Peripheral Nerve Injuries
- What is being tested?
- Symani® Surgical System and Manual Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 18 Dec 2025to 18 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, at the time of nerve injury aged from 18 to 70 years
- Patient agrees to participate in the study, returns for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study and its requirements
- Complete loss of a nerve-specific receptive field of the finger
- Patient with a clinical indication for a microsurgical nerve coaptation in nerve injury that can be repaired by end-to-end suturing
- Patient with traumatic transection of one or more digit nerves distal to the carpal tunnel with sensory autonomous innervation areas on the finger or thumb tips
- Investigator considers candidate acceptable for either conventional epineural suturing or robotic-assisted epineural suturing
- The injury was treated within 10 days
Who cannot join
- Patients who are not capable and/or unwilling to provide informed consent
- Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators' discretion.
- Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
- Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator
- Indication for bilateral nerve repair
- Known impaired sensibility of the injured finger
Show all 13Show fewer
- Patients with implanted pacemaker
- Replantation which includes bones
- Intra-Operative Inclusion Criteria
- Individuals will be included in the study if the following criteria are met intraoperatively:
- 1. Verification of a sensory nerve lesion without a gap and presence of a nerve that could be sutured in end-to-end fashion Intra-Operative Exclusion Criteria
- Individuals will be excluded from participating in this study if any of the following criteria are met intraoperatively:
- 1. Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
BG Klinik Ludwigshafen
Ludwigshafen
Arne Böcker
Arne Böcker
About this study
Official title: REGEN: A Prospective, Randomized, Open Label Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical nerve coaptation, following nerve injuries to the hand.
This study will include participants with traumatic sensory nerve lesions of a finger nerve distal to the carpal tunnel who are treated with nerve suturing.
The primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure.
The primary safety endpoint is the intraoperative serious adverse event rate.
- Conditions
- Nerve Injury, Peripheral Nerve Injuries
- Being tested
- Symani® Surgical System, Manual Surgery
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symani® Surgical SystemDevice
Also called RAS
Robotic-assisted surgery consists of participants who undergo nerve coaptation with the Symani Surgical System, according to the Instruction for Use (IFU). In order for the surgery to be considered a robotic assisted surgery, the participants must be randomized to the RAS group which will include:
- Participants where all nerve coaptations were performed entirely with Symani.
- Participants who underwent a hybrid procedure, where a coaptation was commenced using Symani but a switch to manual suturing occurred during the procedure
Manual SurgeryProcedure or surgery
Also called MS
Manual surgery consists of participants who undergo nerve coaptation through manual techniques by a surgeon using handheld instruments without robotic assistance. In order for the surgery to be considered a manual surgery, the participants must be randomized to the MS group which will include:
- Participants where all nerve coaptations were performed entirely manually.
- Participants who underwent a hybrid procedure, where a coaptation was commenced using manual suturing but a switch to Symani occurred during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted Surgery (RAS) group | Active comparator | Not described Receives: Device: Symani® Surgical System |
| Manual Surgery (MS) group | Active comparator | Not described Receives: Procedure: Manual Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-point discrimination (2PD) test, at 6-months post index procedure.
The primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure.
The two-point discrimination test is a sensory test used to assess the ability of the patient to distinguish between two distant points of touch on the skin. The test measures the minimum distance between two stimulus points on the skin, which are perceived as distinct points. This endpoint will be evaluated at 6-months post index procedure.
Measured: From participants index procedure through 6-months post index procedure
Intraoperative serious adverse event rate
The primary safety endpoint is the intraoperative serious adverse event rate.
The incidence of SAEs occurring during the intra-operative period will be presented. In addition, each participant will be categorized as 'had any SAEs in the intra-operative period' Yes or No. The proportion of participants who experienced any SAEs in the intra-operative period will be presented with exact confidence limits. The difference between groups will also be presented with exact confidence limits.
Measured: The duration of the participants index procedure.
Secondary outcomes (8)
Two-point discrimination test at 3 and 12-months post index procedure
The two-point discrimination test (2PD) will be assessed at 3, 6, 12-months post-surgery. It will be measured in mm.
Descriptive statistics will be presented by surgical group and timepoint. A mixed model for repeated measures (MMRM) will be fitted with 2PD (mm) as the outcome and surgical group, timepoint and surgical group*timepoint as fixed effects. Timepoint will be included as a repeated term (subject=participant) to acknowledge the repeated measures in the study (i.e. a participant will have data for 3, 6, and 12-months). Nerve will also be included as a repeated term (subject=participant) to acknowledge that a participant may have more than one nerve involved. Other terms may be included, as defined in the SAP.
From the model the least squares means (LSM) for each surgical group at each timepoint will be presented with confidence limits (CLs). In addition, the difference in LSMs between groups at each timepoint will be presented with CL.
Measured: From participants index procedure through 3-months and 12-months post-index procedure
Ten Test on sensitivity at 3, 6 and-12 months post index procedure
Ten Test is defined as the assessment of sensory function in the injured and contralateral nerves, using a scale from 0 (no sensitivity) to 10 (full sensitivity). The results will be compared between the injured and contralateral nerves to evaluate sensory function. This endpoint will be evaluated at 3-months, 6-months and 12-months post-index procedure.
Measured: From participants index procedure through 3-months and 12-months post-index procedure
Sensory reinnervation assessment (Semmes-Weinstein monofilament method) at 3, 6 and-12 months post index procedure
Sensory Reinnervation is defined as the smallest filament detected on both the affected and contralateral nerves using the Semmes-Weinstein Monofilament Test. The endpoint will be evaluated at 3-months, 6-months, and 12-months post-index procedure
Measured: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
Gross hand strength assessment (Jamar Dynamometer) at 3, 6 and 12-months after post procedure
Gross Hand Strength is defined as the measurement of hand strength using a dynamometer, recorded in kilograms (kg). Strength will be assessed for both the injured hand and the contralateral hand, with results recorded for each hand. This endpoint will be evaluated at 3-months, 6-months and 12-months post-index procedure.
Measured: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
Thumb strength assessment (Jamar Dynamometer) at 3, 6 and 12-months post index procedure
Thumb Strength Assessment is defined as the measurement of thumb strength using a Jamar Dynamometer, recorded in kilograms (kg). Strength will be assessed for both the injured hand and the contralateral hand. This endpoint will be evaluated at 3-months, 6-months and 12-months post-index procedure.
Measured: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
Range of motion of the injured finger in flexion and extension in comparison with the unaffected side at 3, 6 and 12-months post index procedure
Range of Motion (ROM) is defined as whether the injured finger achieves full flexion and extension compared to the unaffected side. This endpoint will be evaluated at 3-months, 6-months, and 12-months post-index procedure.
Measured: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
Kapandji Score at 3, 6 and 12-months after post procedure
The Kapandji Score will be defined as a measure of thumb opposition, with scores ranging from 0 to 10, where a higher score indicates better thumb mobility and function. Results from each time point will be used to assess changes in thumb opposition and overall hand function. Assessments will be made at 3-months, 6-months and 12-months post-index procedure
Measured: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
DASH questionnaire at 3, 6 and 12-months post index procedure
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire will be used to assess the participants' upper limb function, specifically related to the arm, shoulder, and hand. It measures the severity of symptoms and the impact of musculoskeletal disorders or injuries on daily activities. The DASH questionnaire consists of 30 items covering aspects like physical function, symptoms, and social or work-related limitations. The score ranges from 0 to 100. A higher score indicating greater disability or dysfunction. This questionnaire will be administered to each participant either on paper or electronically at the 3-month, 6-month, and 12-month follow-up visits. The DASH questionnaire will be completed individually by each participant.
The DASH Questionnaire will assess the physical function and symptoms (such as pain and weakness) of the arm, shoulder, and hand, evaluating the participant's ability to perform daily activities. These functio
Measured: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start18 Dec 2025
- Primary completion18 Dec 2026 (estimated)
- Study completion18 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MMI (Medical Microinstruments, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084207
- Sponsor's protocol ID
- CDC-00146
- Acronym
- REGEN
- Status last verified
- Jan 2026
- First submitted
- 3 Jul 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REGEN: A Prospective, Randomized, Open Label Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair
- ClinicalTrials.gov ID
- NCT07084207
- Acronym / sponsor ID
- REGEN / CDC-00146
- Conditions
- Nerve Injury, Peripheral Nerve Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MMI (Medical Microinstruments, Inc.)Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 18 Dec 2027 (estimated)
- First posted
- 24 Jul 2025 (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.
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical nerve coaptation, following nerve injuries to the hand.
This study will include participants with traumatic sensory nerve lesions of a finger nerve distal to the carpal tunnel who are treated with nerve suturing.
The primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure.
The primary safety endpoint is the intraoperative serious adverse event rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted Surgery (RAS) group | Active comparator | Device: Symani® Surgical System |
| Manual Surgery (MS) group | Active comparator | Procedure: Manual Surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults, at the time of nerve injury aged from 18 to 70 years
- Patient agrees to participate in the study, returns for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study and its requirements
- Complete loss of a nerve-specific receptive field of the finger
- Patient with a clinical indication for a microsurgical nerve coaptation in nerve injury that can be repaired by end-to-end suturing
- Patient with traumatic transection of one or more digit nerves distal to the carpal tunnel with sensory autonomous innervation areas on the finger or thumb tips
Key exclusion criteria (13 listed)
- Patients who are not capable and/or unwilling to provide informed consent
- Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators' discretion.
- Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
- Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator
- Indication for bilateral nerve repair
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 |
|---|---|---|
| Symani® Surgical SystemAlso: RASRobotic-assisted surgery consists of participants who undergo nerve coaptation with the Symani Surgical System, according to the Instruction for Use (IFU). In order for the surgery to be considered a robotic assisted surgery, the participants must be randomized to the RAS group which will include: * Participants where all nerve coaptations were performed entirely with Symani. * Participants who underwent a hybrid procedure, where a coaptation was commenced using Symani but a switch to manual suturing occurred during the procedure | Device | Robotic-Assisted Surgery (RAS) group |
| Manual SurgeryAlso: MSManual surgery consists of participants who undergo nerve coaptation through manual techniques by a surgeon using handheld instruments without robotic assistance. In order for the surgery to be considered a manual surgery, the participants must be randomized to the MS group which will include: * Participants where all nerve coaptations were performed entirely manually. * Participants who underwent a hybrid procedure, where a coaptation was commenced using manual suturing but a switch to Symani occurred during the procedure. | Procedure or surgery | Manual Surgery (MS) group |
Primary outcome
Two-point discrimination (2PD) test, at 6-months post index procedure.
Time frame: From participants index procedure through 6-months post index procedure
The primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure. The two-point discrimination test is a sensory test used to assess the ability of the patient to distinguish between two distant points of touch on the skin. The test measures the minimum distance between two stimulus points on the skin, which are perceived as distinct points. This endpoint will be evaluated at 6-months post index procedure.
Intraoperative serious adverse event rate
Time frame: The duration of the participants index procedure.
The primary safety endpoint is the intraoperative serious adverse event rate. The incidence of SAEs occurring during the intra-operative period will be presented. In addition, each participant will be categorized as 'had any SAEs in the intra-operative period' Yes or No. The proportion of participants who experienced any SAEs in the intra-operative period will be presented with exact confidence limits. The difference between groups will also be presented with exact confidence limits.
8 secondary outcomes
Two-point discrimination test at 3 and 12-months post index procedure
Time frame: From participants index procedure through 3-months and 12-months post-index procedure
Ten Test on sensitivity at 3, 6 and-12 months post index procedure
Time frame: From participants index procedure through 3-months and 12-months post-index procedure
Sensory reinnervation assessment (Semmes-Weinstein monofilament method) at 3, 6 and-12 months post index procedure
Time frame: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
Gross hand strength assessment (Jamar Dynamometer) at 3, 6 and 12-months after post procedure
Time frame: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
Thumb strength assessment (Jamar Dynamometer) at 3, 6 and 12-months post index procedure
Time frame: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
Range of motion of the injured finger in flexion and extension in comparison with the unaffected side at 3, 6 and 12-months post index procedure
Time frame: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
Kapandji Score at 3, 6 and 12-months after post procedure
Time frame: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
DASH questionnaire at 3, 6 and 12-months post index procedure
Time frame: From participants index procedure through 3-months, 6-months and 12-months post-index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symani® Surgical System and Manual Surgery in people with Nerve Injury and Peripheral Nerve Injuries, run by MMI (Medical Microinstruments, Inc.) at 1 site in Germany.
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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (8336646276, clinical.ops@mmimicro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-point discrimination (2PD) test, at 6-months post index procedure. (time frame: From participants index procedure through 6-months post index procedure). The study lists 2 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 3 Feb 2026.