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The Efficacy and Safety of a Latest Dural Substitute (ESLO)

Primary Purpose

Cerebrospinal Fluid Leak

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Lyoplant Onlay

DURAFORM

About this trial

This is an interventional treatment trial for Cerebrospinal Fluid Leak focused on measuring Dura Mater, Cerebrospinal Fluid Leak

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Any patient between the ages of 18 and 75 years scheduled for elective cranial surgery involving a dural incision.
Dural defects and surgical incision was classifed as level 1

Exclusion Criteria:

local or systemic infection.
patients with known allergy to Equipment components
a history of traumatic head injury
a compromised immune system or autoimmune disease
patients who should not participate based on the surgeon's opinion
patients participating in any other drug or device trial.
expected survival time <12 months
underwent chemoradiotherapy 3 months before randomization
uncontrolled diabetes and malignant tumor
women who were pregnant, lactating, or wished to become pregnant during the study;

Sites / Locations

Jianmin ZhangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

DURAFORM

Lyoplant Onlay

Arm Description

DURAFORM was used in repairing cerebral dura mater.

Lyoplant Onlay was used in repairing cerebral dura mater.

Outcomes

Primary Outcome Measures

surgical successful rate

proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure.

Secondary Outcome Measures

neurosurgical complication

Incidence of intracranial infection at 2 days after operation，at discharge，and at 30 days after operation

Full Information

NCT ID

NCT04490629

First Posted

July 16, 2020

Last Updated

July 26, 2020

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04490629

Brief Title

The Efficacy and Safety of a Latest Dural Substitute

Acronym

ESLO

Official Title

A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

November 1, 2020 (Anticipated)

Study Completion Date

November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This prospective, multi-center, randomized, parallel-controlled clinical trial was designed to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater. DURAFORM was regarded as the control group. a total of 80 patients were randomized into experimental and control group (1:1).Data were collected on complications resulting in CSF leaks, surgical site infections, instrument performance parameterized other neurological complications within 30 days. Surgeons also provided data on the ease of use of the dural sealing techniques, as well as preparation and application times. The above-mentioned date were used to evaluate the efficacy and safety of Lyoplant Onlay .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebrospinal Fluid Leak

Keywords

Dura Mater, Cerebrospinal Fluid Leak

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DURAFORM

Arm Type

Other

Arm Description

DURAFORM was used in repairing cerebral dura mater.

Arm Title

Lyoplant Onlay

Arm Type

Experimental

Arm Description

Lyoplant Onlay was used in repairing cerebral dura mater.

Intervention Type

Device

Intervention Name(s)

Lyoplant Onlay

Intervention Description

Lyoplant Onlay is a kind of latest artificial Dura Mater

Intervention Type

Device

Intervention Name(s)

DURAFORM

Intervention Description

DURAFORM is a kind of conventional artificial Dura Mater

Primary Outcome Measure Information:

Title

surgical successful rate

Description

proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure.

Time Frame

at 30 days post surgery

Secondary Outcome Measure Information:

Title

neurosurgical complication

Description

Incidence of intracranial infection at 2 days after operation，at discharge，and at 30 days after operation

Time Frame

2 days post surgery/10 days post surgery/at 30 days post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Any patient between the ages of 18 and 75 years scheduled for elective cranial surgery involving a dural incision. Dural defects and surgical incision was classifed as level 1 Exclusion Criteria: local or systemic infection. patients with known allergy to Equipment components a history of traumatic head injury a compromised immune system or autoimmune disease patients who should not participate based on the surgeon's opinion patients participating in any other drug or device trial. expected survival time <12 months underwent chemoradiotherapy 3 months before randomization uncontrolled diabetes and malignant tumor women who were pregnant, lactating, or wished to become pregnant during the study;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jianmin Zhang, M.D.

Phone

+86 0571 87784755

zjm135@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

jianmin zhang, M.D.

Organizational Affiliation

Department of neurosurgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jianmin Zhang

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianmin Zhang, M.D., Ph.D.

Phone

+86 0571 87784755.

zjm135@zju.edu.cn

First Name & Middle Initial & Last Name & Degree

Jianmin Zhang, M.D.，Ph.D.

First Name & Middle Initial & Last Name & Degree

Junming Zhu, M.D.

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The committee will debate whether to share IPD depending on the circumstances. Because some patients are unwilling to make their condition known.

Learn more about this trial

The Efficacy and Safety of a Latest Dural Substitute

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