Ignite Creation Date:
2024-05-06 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03673449
Status:
UNKNOWN
Last Update Posted:
2020-03-18
First Post:
2018-09-12
Brief Title:
Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
Sponsor:
Silk Biomaterials srl
Organization:
Silk Biomaterials srl
Study Overview
Official Title:
A Pilot Study to Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to ascertain the feasibility and safety of the procedure using SilkBridge - a biocompatible silk fibroin-based scaffold - for the regeneration of sensory nerve fibres and follow it up together with the reinnervation of the target organs sensory receptors in the skin
Detailed Description:
This is a pre-market monocentre first-in-human pilot on adult patients with digital nerve defects Category C clinical trial medical devices The study will be performed in Switzerland
SilkBridge is a biocompatible silk fibroin-based scaffold which recruits the patients own cells to remodel or regenerate the nerve without pre-seeding of the scaffold nor biologicalchemical treatments
SilkBridge will provide surgeons with an implant with unique features such as easy suturability full biocompatibility and specific biomimetic properties that enhance cells adhesion and integration of the device with the surrounding tissue
The study will have a 12 months and 1 week duration per patient including the follow-up period and with an expected enrollment period of 15 months
The study will evaluate 15 adult patients aged 18-65 years diagnosed with digital nerve defects 5 mm gap in whom surgical repair may not allow direct suture
SilkBridge is a biocompatible silk fibroin-based scaffold which recruits the patients own cells to remodel or regenerate the nerve without pre-seeding of the scaffold nor biologicalchemical treatments
SilkBridge will provide surgeons with an implant with unique features such as easy suturability full biocompatibility and specific biomimetic properties that enhance cells adhesion and integration of the device with the surrounding tissue
The study will have a 12 months and 1 week duration per patient including the follow-up period and with an expected enrollment period of 15 months
The study will evaluate 15 adult patients aged 18-65 years diagnosed with digital nerve defects 5 mm gap in whom surgical repair may not allow direct suture
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None