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

NCT ID: NCT03780855

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-14

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Peripheral Nerve Injuries

Keywords

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scaffold Peripheral nerve injures repair safety effectiveness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nerve scaffold group

the experimental group of cases with peripheral sensory nerve injuries will be treated with nerve scaffold.

Group Type EXPERIMENTAL

nerve scaffold

Intervention Type DEVICE

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.

non-nerve scaffold group

the control group of cases will be treated without nerve scaffold.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhuo j Luo, MD

Role: STUDY_CHAIR

Xijing Hospital

Rui Cong, MD

Role: STUDY_DIRECTOR

Xijing Hospital

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing h Huang, MD

Role: CONTACT

Phone: 13572066464

Email: [email protected]

Facility Contacts

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Jing h Huang, MD

Role: primary

Other Identifiers

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KY20172005-1

Identifier Type: -

Identifier Source: org_study_id