NCT00394459

Brief Summary

Primary Objective: The primary objective is to demonstrate that the safety of Perifix New is non-inferior to using Perifix Standard when applied for thoracic epidural anaesthesia. Primary Endpoint: Incidence of spontaneous paraesthesia during catheter insertion Secondary Objectives: The secondary objectives are to determine the safety and performance of the investigational product: frequency of inadvertent vascular cannulation, difficulties involved in insertion and removal of the catheter, other safety features and data for the evaluation of handling characteristics. Title: Randomised, prospective, single-blind, controlled, study on the safety of two epidural catheters in patients undergoing surgery under thoracic epidural anaesthesia Investigational Product: Perifix Epidural Anaesthesia Catheter Test Product: Perifix New Reference Product: Perifix Standard Number of Sites and Countries: 1 site in The Netherlands Indication: Thoracic epidural anaesthesia Study Design: Randomised, prospective, single-blind, controlled study in 1 study center, phase IV Perifix New and Perifix Standard meet all the appropriate provisions of the relevant legislation implementing European Directives (both have CE-marking). Study Duration: 2 year duration Study Start: March-April 2005 Sample Size: n = 2\*70 patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

2.9 years

First QC Date

October 31, 2006

Last Update Submit

May 12, 2011

Conditions

Anesthesia, EpiduralParaesthesia

Keywords

Anaesthetic techniquesepiduralcathetersparaesthesiaside effectsAnesthesia, Epidural [E03.155.086.131]

Outcome Measures

Primary Outcomes (1)

  • The primary end-point will be the incidence of spontaneous paraesthesia during catheter insertion in TEA-patients.

    1 hour

Secondary Outcomes (4)

  • The frequency of inadvertent vascular cannulation

    1 hour

  • Difficulties involved in insertion and removal of the catheter

    1 week

  • Data on additional complications

    1 week

  • Data for the evaluation of handling characteristics

    1 week

Study Arms (2)

A

ACTIVE COMPARATOR

Perifix Standard

Device: Perifix Epidural Anaesthesia CatheterDevice: Perifix Standard

B

EXPERIMENTAL

Perifix New

Device: Perifix Epidural Anaesthesia CatheterDevice: Perifix New

Interventions

Perifix Epidural Anaesthesia CatheterDEVICE

Epidural Catheter

AB
Perifix StandardDEVICE

Perifix Standard

A
Perifix NewDEVICE

Perifix New

B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for thoracic epidural anaesthesia (TEA), with or without general anaesthesia.
  • American Society of Anesthesiologists (ASA) class I-III
  • Patients aged 18 and ≤ 75 years of age

You may not qualify if:

  • Severe scoliosis, previous surgery on the spine, M. Bechterew disease
  • Non-competent and non-cooperative patients
  • Patients with medicament and drug abuse problems, problems in communication, participating in parallel in another clinical study with experimental drugs or devices, receiving prohibited concomitant therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Paresthesia

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mathieu Gielen, MD, PhD

    Radboud University Medical Center

    STUDY CHAIR

  • Marco Marcus, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 1, 2006

Study Start

April 1, 2005

Primary Completion

March 1, 2008

Study Completion

May 1, 2009

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations

NL(1)