- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03780855
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
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
Interventional
Enrollment (Anticipated)
10
Phase
- 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
- Name: Jing h Huang, MD
- Phone Number: 13572066464
- Email: huangjh@fmmu.edu.cn
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Hospital
-
Contact:
- Jing h Huang, MD
- Phone Number: 13572066464
- Email: huangjh@fmmu.edu.cn
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: nerve scaffold group
the experimental group of cases with peripheral sensory nerve injuries will be treated with 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
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
Investigators
- 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)
June 14, 2017
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
November 26, 2018
First Submitted That Met QC Criteria
December 17, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
December 19, 2018
Last Update Submitted That Met QC Criteria
December 17, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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