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

NCT03780855 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-12-19

No results posted yet for this study

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.

Conditions

  • Peripheral Nerve Injuries

Interventions

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.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Zhuo j Luo, MD · Xijing Hospital

  • Rui Cong, MD · Xijing Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03780855 on ClinicalTrials.gov