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

NCT07385872 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

  • Primary Condition: Nerve Block
  • Secondary Condition: Catheter Displacement
  • Focus of Study: Sciatic Nerve

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).

Sponsors & Collaborators

  • Hvidovre University Hospital

    collaborator OTHER

  • Nordstar Medical

    collaborator UNKNOWN

  • Nordsjaellands Hospital

    lead OTHER

Principal Investigators

  • Christoffer C Jørgensen, MD, PhD · Nordsjaellands Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-08-31
Completion
2026-11-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07385872 on ClinicalTrials.gov