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

December 17, 2018 updated by: Xijing Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: nerve scaffold group
the experimental group of cases with peripheral sensory nerve injuries will be treated with nerve scaffold.
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.
No Intervention: non-nerve scaffold group
the control group of cases will be treated without nerve scaffold.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Observing the condition of the healing of local wound with the naked eye at 2 weeks after operation，including redness, exudation and ulceration.
Time Frame: 2 weeks after operation
The condition of the healing of local wound will be observed by the designated doctor with the naked eye to see if there is redness, exudation or ulceration. And then the condition will be recorded.
2 weeks after operation
Learning about patients' systemic reactions by asking them at 2 weeks after operation, including fever, nausea, vomiting and skin itching.
Time Frame: 2 weeks after operation
The patients will be asked if there is systemic discomfort or any other bad reactions during the 2 weeks, including fever, nausea, vomiting and skin itching. And then the condition will be recorded.
2 weeks after operation
Test of white blood cell count at 2 weeks after operation
Time Frame: 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
2 weeks after operation
Test of lymphocyte count at 2 weeks after operation
Time Frame: 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
2 weeks after operation
Test of red blood cell count at 2 weeks after operation
Time Frame: 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
2 weeks after operation
Test of hemoglobin concentration at 2 weeks after operation
Time Frame: 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
2 weeks after operation
Test of platelet count at 2 weeks after operation
Time Frame: 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
2 weeks after operation
Test of alanine aminotransferase at 2 weeks after operation
Time Frame: 2 weeks after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
2 weeks after operation
Test of aspartate aminotransferase at 2 weeks after operation
Time Frame: 2 weeks after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
2 weeks after operation
Test of serum creatinine at 2 weeks after operation
Time Frame: 2 weeks after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
2 weeks after operation
Test of blood urea nitrogen at 2 weeks after operation
Time Frame: 2 weeks after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
2 weeks after operation
Test of prothrombin time at 2 weeks after operation
Time Frame: 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
2 weeks after operation
Test of activated partial thromboplastin time at 2 weeks after operation
Time Frame: 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
2 weeks after operation
Test of thrombin time at 2 weeks after operation
Time Frame: 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
2 weeks after operation
Examination of the position sense at 3 months after operation
Time Frame: 3 months after operation
The position sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is a kind of deep sense.
3 months after operation
Examination of the movement sense at 3 months after operation
Time Frame: 3 months after operation
The movement sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is another kind of deep sense.
3 months after operation
Examination of the sense of light touch at 3 months after operation
Time Frame: 3 months after operation
The sense of light touch of the area innervated by the repaired nerve will be examined by the designated doctor, which is one of the superficial sense categories.
3 months after operation
Examination of the sense of pain at 3 months after operation
Time Frame: 3 months after operation
The sense of pain of the area innervated by the repaired nerve will be examined by the designated doctor, which is another one of the superficial sense categories.
3 months after operation
Examination of the sense of temperature at 3 months after operation
Time Frame: 3 months after operation
The sense of temperature of the area innervated by the repaired nerve will be examined by the designated doctor, which also belongs to the superficial sense categories.
3 months after operation
Examination of static two-point discrimination at 3 months after operation
Time Frame: 3 months after operation
The static two-point discrimination of the area innervated by the repaired nerve will be examined by the designated doctor.
3 months after operation
Test of white blood cell count at 3 months after operation
Time Frame: 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
3 months after operation
Test of lymphocyte count at 3 months after operation
Time Frame: 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
3 months after operation
Test of red blood cell count at 3 months after operation
Time Frame: 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
3 months after operation
Test of hemoglobin concentration at 3 months after operation
Time Frame: 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
3 months after operation
Test of platelet count at 3 months after operation
Time Frame: 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
3 months after operation
Test of alanine aminotransferase at 3 months after operation
Time Frame: 3 months after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
3 months after operation
Test of aspartate aminotransferase at 3 months after operation
Time Frame: 3 months after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
3 months after operation
Test of serum creatinine at 3 months after operation
Time Frame: 3 months after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
3 months after operation
Test of blood urea nitrogen at 3 months after operation
Time Frame: 3 months after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
3 months after operation
Test of prothrombin time at 3 months after operation
Time Frame: 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
3 months after operation
Test of activated partial thromboplastin time at 3 months after operation
Time Frame: 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
3 months after operation
Test of thrombin time at 3 months after operation
Time Frame: 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
3 months after operation
Examination of the position sense at 6 months after operation
Time Frame: 6 months after operation
The position sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is a kind of deep sense.
6 months after operation
Examination of the movement sense at 6 months after operation
Time Frame: 6 months after operation
The movement sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is another kind of deep sense.
6 months after operation
Examination of the sense of light touch at 6 months after operation
Time Frame: 6 months after operation
The sense of light touch of the area innervated by the repaired nerve will be examined by the designated doctor, which is one of the superficial sense categories.
6 months after operation
Examination of the sense of pain at 6 months after operation
Time Frame: 6 months after operation
The sense of pain of the area innervated by the repaired nerve will be examined by the designated doctor, which is another one of the superficial sense categories.
6 months after operation
Examination of the sense of temperature at 6 months after operation
Time Frame: 6 months after operation
The sense of temperature of the area innervated by the repaired nerve will be examined by the designated doctor, which also belongs to the superficial sense categories.
6 months after operation
Examination of static two-point discrimination at 6 months after operation
Time Frame: 6 months after operation
The static two-point discrimination of the area innervated by the repaired nerve will be examined by the designated doctor.
6 months after operation
Test of white blood cell count at 6 months after operation
Time Frame: 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
6 months after operation
Test of lymphocyte count at 6 months after operation
Time Frame: 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
6 months after operation
Test of red blood cell count at 6 months after operation
Time Frame: 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
6 months after operation
Test of hemoglobin concentration at 6 months after operation
Time Frame: 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
6 months after operation
Test of platelet count at 6 months after operation
Time Frame: 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
6 months after operation
Test of alanine aminotransferase at 6 months after operation
Time Frame: 6 months after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
6 months after operation
Test of aspartate aminotransferase at 6 months after operation
Time Frame: 6 months after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
6 months after operation
Test of serum creatinine at 6 months after operation
Time Frame: 6 months after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
6 months after operation
Test of blood urea nitrogen at 6 months after operation
Time Frame: 6 months after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
6 months after operation
Test of prothrombin time at 6 months after operation
Time Frame: 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
6 months after operation
Test of activated partial thromboplastin time at 6 months after operation
Time Frame: 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
6 months after operation
Test of thrombin time at 6 months after operation
Time Frame: 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
6 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zhuo j Luo, MD, Xijing Hospital
  • Study Director: Rui Cong, MD, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20172005-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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