Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07385872
NA

Performance of a Novel Concept for Internal Fixation of a Novel Peripheral Nerve Block Catheter

Sponsor: Nordsjaellands Hospital

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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