MedTrace Logo

Respiration Gated Laser Guided CT Lung Nodule Biopsy

NCT01236937 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2010-11-09

No results posted yet for this study

Summary

The primary outcome of this study is to investigate the accuracy of respiration gated laser guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based breath hold monitoring system. Secondary outcome is the rate of complications using laser guided CT biopsy in general and with bellows-based breath hold monitoring system. The study has approval from the The Danish National Committee on Biomedical Research Ethics (ref no: H-4-2010-fsp 1).

Conditions

Interventions

DEVICE

Bellows-based breath hold device

Bellows-Based breath hold monitoring system: The bellows-based breath hold system (IBC, Mayo Clinic Medical Devices, USA) contains of 2 elements; one belt which is strapped around the thorax of the patient and a voltage controlled light unit with 8 lights. Belt stretch from respiratory motion is converted into voltage readings and displayed on the light unit giving biofeedback as different lights are activated depending on the dept of the respiration. Patients are instructed to keep respiration constant at a certain dept during the second the guide needle is inserted by controlling their breath with the help of the light unit. The patient is given a brief introduction to the system as to how the lights get turned on and off due to respiration motion before the biopsy is preformed.

Sponsors & Collaborators

  • University Hospital, Gentofte, Copenhagen

    lead OTHER

Principal Investigators

  • Haseem Ashraf, MD, PhD · Gentofte University Hospital, Department of Radiology

  • Paul Clementsen, MD, PhD · Gentofte University Hospital, Department of Pulmonology

  • Annete Nørgaard, MD, PhD · Gentofte University Hospital, Department of Pulmonology

  • Peter S. Myschetzky, MD · Gentofte University Hospital, Department of Radiology

  • Asger Dirksen, MD, PhD · Gentofte University Hospital, Department of Pulmonology

  • Zaigham Saghir, MD · Gentofte University Hospital, Department of Pulmonology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-03-31
Completion
2012-07-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT01236937 on ClinicalTrials.gov