- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01279148
Electromagnetic Tracking of Devices During Interventional Procedures
Study Overview
Status
Conditions
Detailed Description
The study will consist of approximately 300 patients from 1 sites. Each site will have a study group, where the physician will use the electromagnetic tracking system along with "US" ultrasound or "CT" computed tomography to complete the procedure and a control group, where the electromagnetic tracking system will be used, but the physician will be blinded to it and use only the typical, standard, conventional protocol, using US or CT, to complete the procedure. The expected completion time for enrollment is 12 months, but will depend on the ability of each Clinic to enroll patients.
Data and observations will be collected at a total of 2 scheduled appointments (screening and 1 study visit) or based on the current hospital workflow, which may combine these into one patient encounter.
Study Type
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Has had a pre-operative CT scan performed and will be undergoing a biopsy or ablation procedure of the chest, abdomen and/or pelvis;
- Is over the age of 18;
- Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol;
- Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure.
Exclusion Criteria:
- Was precluded from a biopsy/ablation procedure based on standard exclusions;
- Has an adhesive allergy (due to the application of active fiducials with adhesive backing);
- Has a pacemaker or automatic implantable cardiac defibrillator;
- Has a gross body weight above the procedural table limit (typically > 170 kg);
- Is pregnant
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Biopsy/Ablation - CONTROL GROUP
The tracking device will be placed on the patient's skin at the desired point of entry.
Without displaying the PercuNav screen to the physician, a screen capture will be taken to record the approach path.
At the point of insertion, the time stamp will be recorded and the start button will be pressed.
Once the physician states they are at the defined target a screen capture will be taken on the PercuNav and the distance to target and time stamp will be recorded by pushing the start button again.
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Biopsy/Ablation - STUDY GROUP:
The tracking device will be placed on the patient's skin at the desired point of entry.
Without displaying the PercuNav screen to the physician, a screen capture will be taken to record the approach path.
The physician will then be un-blinded and shown the PercuNav screen and will correct the desired approach path and another screen capture will be taken.
At the point of insertion, the time stamp will be recorded and the start button will be pressed.
Once the physician states they are at the defined target a screen capture will be taken on the PercuNav and the distance to target and time stamp will be recorded.
At the end of the procedure, and if clinically indicated, a verification "CT" computed tomography scan will be taken with the needle in place and, sent to the PercuNav.
Radiation dosage, due to CT imaging, will also be recorded.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Registration Error
Time Frame: Day 1
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"TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of ablation as determined by imaging
Time Frame: 3 months
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Primary effectiveness (success of ablation in local tumor control or success of biopsy in diagnostic biopsy sample).
Successful ablation equals complete tumor ablation with a 5mm-1cm margin of normal tissue (if possible; quantified by the lack of enhancement of intravenous contrast material at 3 month follow up CT).
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3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2010 MCT V7
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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