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Performance of a Novel Concept for Internal Fixation of a Novel Peripheral Nerve Block Catheter
Sponsor: Nordsjaellands Hospital
Summary
The goal of this study is to test a new type of nerve block catheter (a thin, flexible tube used to deliver pain medication). Researchers want to see if this new design stays in its original position better than current catheters and if it is easy for doctors to use. The main questions the study aims to answer are: Does the catheter tip stay in the correct position over time without moving or slipping (dislocation)? Can the catheter be placed quickly and accurately using the new deployment system? Researchers will test this prototype in a small group of participants. There is no comparison group for this initial study. Participants will: Have the catheter placed near a nerve in their leg a few days before a scheduled femoral (leg) amputation. Undergo imaging or checks to see if the catheter has moved. Have the catheter removed just before their scheduled surgery. The catheter will be placed in an area of the leg that is already scheduled to be removed during surgery. This ensures that the study carries minimal risk to the participants.
Official title: Feasibility and Performance of a Novel Concept for Internal Fixation of a Peripheral Nerve Block Catheter in Patients Undergoing Femoral Amputation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-02
Completion Date
2026-11
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve
A peripheral nerve block catheter prototype featuring internal fixation to prevent dislocation and a rapid-deployment system. Catheters are placed under ultrasound guidance.
Novel Internal Fixation Nerve Block Catheter - Saphenous nerve
Placement of the saphenous catheter is contingent upon an amputation line that allows for placement below the surgical site (distal to the cut).
Locations (1)
Hvidovre Hospital
Copenhagen, Capital Region, Denmark