Mid-term Effect Observation of Biodegradable Conduit Smal... | NCT03359330

Studies
Mid-term Effect Observation of Biodegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury

NCT03359330

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Dec 2, 2017Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Peripheral Nerve Injuries

Interventions

Degradable Conduit Small Gap Tublization

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Nov 26, 2017

First Submission Date that Met QC Criteria

Nov 30, 2017

First Posted Date

Dec 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2017

Last Update Posted Date

Dec 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhang Peixun, Department of orthopaedics and trauma, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To observe the Mid-term clinical effect of biodegradable conduit small gap tublization to repair peripheral nerve injury in multi-center．

Detailed Description

In the study，150 cases of fresh peripheral nerve injury in the upper extremities are recruited in multi-center． After formally informed and obtaining the consent，the biodegradable conduit small gap tublization are used to repair the nerve．Their nerve functional recovery conditions are clinically observed according to the standard score methods provided by SHEN Ning-jiang and British Medical Research Council at 3 years after surgery．The excellent and good rates of the overall nerve functional recovery are calculated．

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Degradable conduit small gap tublization		patients with fresh peripheral nerve injury in the upper extremities,repaired with degradable conduit small gap tublization	Other: Degradable Conduit Small Gap Tublization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Degradable Conduit Small Gap Tublization	Other	Degradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury	Degradable conduit small gap tublization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nerve function 1	standard score methods provided by British Medical Research Council	3 years after surgery

Secondary Outcomes

Measure	Description	Time Frame
Nerve function 2	standard score methods provided by Shen Ningjiang Using MSA system	3 years after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

fresh peripheral nerve injury in the upper extremities

Exclusion Criteria:

acute myocardial infarction history within 6 months,
old and pathological peripheral nerve injury,
acute and chronic infection,
various consumptive diseases
unable to tolerate surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

patients with fresh peripheral nerve injury in the upper extremities, requiring surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peixun Zhang, MD	Contact	0118613611237628		zhangpeixun@126.comb

Overall Officials

Name	Affiliation	Role
Peixun Zhang, MD	Department of orthopaedics and trauma	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059348	Peripheral Nerve Injuries
D010523	Peripheral Nervous System Diseases
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided