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New treatment option for Nerve Injury
Official title A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair
ClinicalTrials.gov ID: NCT07084207
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Pre-Operative
- 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...
- 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
You likely can't join if
- 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...
- 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...
- Indication for bilateral nerve repair
- Known impaired sensibility of the injured finger
See the full eligibility criteria
- Pre-Operative
- 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
- 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...
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Ludwigshafen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ludwigshafen, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.