NCT03780855

Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold

Preliminary Evaluation of the Safety and Effectiveness of the Bionic Nerve Scaffold With Longitudinally Oriented Microchannels in Clinical Application

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels. 10 patients with peripheral sensory nerve defects will be involved and divided into 2 groups: the experimental group is treated with the nerve scaffold, and the control group without that. Then follow the cases up and draw conclusion according to the results of observation and examination.

Detailed description

The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels developed in the Department of Orthopaedics in Xijing hospital in repairing the peripheral nerve defect. According to the inclusion and exclusion criteria, 10 patients with peripheral sensory nerve defects of 1 to 3 cm in size will be involved. Divided them into 2 groups. The experimental group of 5 cases will be treated with the nerve scaffold, and the control group without that. Then follow the cases up at about 2 weeks, 3 months and 6 months after surgery. Observe the condition of the healing of the local wound and the whole body of the 10 patients. Examine the blood routine and biochemical indexes of the experimental group. Sensory recovery of injured nerves will be tested at about 3 months and 6 months after surgery. Record the results in the case report forms. Analyze the data statistically and draw conclusion.

Conditions

• Peripheral Nerve Injuries

Interventions

Type	Name	Description
DEVICE	nerve scaffold	It is a new kind of nerve scaffold with the microstructure of longitudinally oriented microchannels. It's made of collagen as the main raw material.

Timeline

• Start date: 2017-06-14
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-12-19
• Last updated: 2018-12-19

Locations

1 site across 1 country: China