Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Revision Spine Surgery

NACompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

October 22, 2018

Primary Completion Date

November 30, 2020

Study Completion Date

November 30, 2020

Conditions
Spine Surgery
Interventions
DEVICE

CADISS

"The CADISS® device was procured from AuXin Surgery. It consists in three elements:~1. A single use disposable Remote Kit, containing a sterile cartridge, which prepares the Drug Product immediately before use, and the sterile tubing for fluid connexion. The Drug Product is a 30 ml sterile 5% mesna solution of pH 7.3+/-0.5~2. Reusable stainless steel non-cutting mechanical instruments similar to those used in the normal practice, except for the provision of an internal irrigation channel bringing the Drug Product at the working edge.~3. A pedal controlled electric motor driving the peristaltic cassette included in the disposable tubing in order to control the dispensing of the Drug Product during the procedure."

Trial Locations (1)

1348

AuXin Surgery, Louvain-la-Neuve

All Listed Sponsors
lead

AuXin Surgery SA

INDUSTRY

NCT05016739 - Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Revision Spine Surgery | Biotech Hunter | Biotech Hunter