Status:
UNKNOWN
Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold
Lead Sponsor:
Xijing Hospital
Conditions:
Peripheral Nerve Injuries
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 senso...
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 Ort...
Eligibility Criteria
Inclusion
- age from 18-50 yeas old, male or female, course of disease is within one year;
- good heart, liver and kidney function;
- with peripheral sensory nerve defects of 1-3 cm in size, and willing to repair it with the nerve scaffold;
- no significant damage existing in the skin and soft tissue in the operative region
- have signed the informed consent form
- good adherence and willing to return for follow-up visits as required.
Exclusion
- with acute or severe infection
- suffering from serious primary diseases of heart, brain, liver and kidney, blood system, endocrine system and so on, and can not tolerate surgery
- with histories of peripheral vascular disease, immunological disorder chronic alcoholism, and drug abuse and so on
- with family history of genetic
- allergic to collagen and chitosan
- pregnancy and lactating women
- serious damage existing in the skin and soft tissue in the operative region
- bad adherence and can not return for follow-up visits on time as required
Key Trial Info
Start Date :
June 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03780855
Start Date
June 14 2017
End Date
December 1 2019
Last Update
December 19 2018
Active Locations (1)
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1
Xijing Hospital
Xi'an, Shaanxi, China, 710032