LYON: Assessment of the Performance of LYoplant® ONlay for Duraplasty

Sponsor

Aesculap AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02678156

Collaborator

(none)

Enrollment

Locations

22.6

Actual Duration (Months)

20.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.

Condition or Disease	Intervention/Treatment	Phase
Craniotomy Duraplasty Spinal Surgery	Device: Lyoplant Onlay

Study Design

Study Type:

Observational

Actual Enrollment :

61 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Feb 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
LYoplant ONlay Primary objective of the study is the generation of clinical data in patients receiving Lyoplant® Onlay for dura repair to assess its safety.	Device: Lyoplant Onlay

Arm

Intervention/Treatment

LYoplant ONlay

Primary objective of the study is the generation of clinical data in patients receiving Lyoplant® Onlay for dura repair to assess its safety.

Device: Lyoplant Onlay

Outcome Measures

Primary Outcome Measures

Incidence of re-operation because of Cerebrospinal Fluid leakage [until discharge (approximately 1 week)]

Secondary Outcome Measures

Incidence of re-operation because of Cerebrospinal Fluid leakage [until follow-up (4 ± 2 months)]
Incidence of post operative complications [until discharge (approximately 1 week, 4±2 months)]
Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others
Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage [until discharge (approximately 1 week, 4±2 months)]
detected during routine post operative MRI / CT examinations
Intraoperative handling of the device [Intraoperative]
Intraoperative handling of the device using a questionnaire containing different dimension and a 5 point (1 = excellent, 5 = unacceptable) assessment level (Likert Scale). The following dimensions are assessed: Ease of cutting Needle penetration Adaptation to the tissue Suture retention strength Onlay effect Quality of sealing Thickness Tensile strength Overall satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay
Written informed consent
Life expectancy > 6 months
Age > 18 years