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A randomized, single-blind, parallel-controlled, non-inferior, multi-center clinical trial on the safety and effectiveness of artificial nerve implants in the repair of peripheral nerve injuries

A randomized, single-blind, parallel-controlled, non-inferior, multi-center clinical trial on the safety and effectiveness of artificial nerve implants in the repair of peripheral nerve injuries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113049
Enrollment
Unknown
Registered
2025-11-24
Start date
2024-07-29
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral nerve injury

Interventions

Experimental group:Repair the injured peripheral nerve
Control group:Repair the injured peripheral nerve

Sponsors

Shanghai sixth people's hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old<=age<=70 years old; 2. Suitable for patients with acute or chronic peripheral nerve injury repair, with decreased or absent sensory function (BMRC<S3); 3. Neurolysis injuries can be directly treated with tension-free anastomosis or bridging of small gaps with nerve defects<=2cm; 4. Those who voluntarily participate in this experimental study and agree to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are unable or intolerant to surgical treatment; 2. Patients with a history of severe allergies; 3. Patients with autoimmune diseases or other serious physical illnesses that may affect this study; 4. Individuals with mental system disorders and lack of autonomous behavioral ability; 5. Central nervous system injury or spinal cord perforation; 6. Pregnant or breastfeeding period, or those with pregnancy plans within 12 months; 7. Those who are allergic to the implant material collagen or chitosan; 8. Participants in other clinical trials within the past 3 months; 9. Researchers determine other situations that are not suitable for participation in the experiment.

Design outcomes

Primary

MeasureTime frame
British Medical Research Council ,BMRC;Visual analogue scale, VAS;

Secondary

MeasureTime frame
British Medical Research Council ,BMRC;Product Usability Satisfaction;

Countries

China

Contacts

Public ContactFan Cunyi

Shanghai sixth people's hospital

cyfan@sjtu.edu.cn+86 189 3017 7799

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026