Biopsy or Ablation ProceduresNCT01279148
Electromagnetic Tracking of Devices During Interventional Procedures
An observational study of Biopsy or Ablation Procedures, run by Philips Healthcare at 1 site in United States.
Trial summary
This prospective, randomized, controlled, parallel-design trial will compare the use of electromagnetic tracking and image guidance during biopsy/ablation procedures verses the typical standard or conventional image guided procedure alone (control). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biopsy or Ablation Procedures
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitals and Out-patient Clinics
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
This prospective, randomized, controlled, parallel-design trial will compare the use of electromagnetic tracking and image guidance during biopsy/ablation procedures verses the typical standard or conventional image guided procedure alone (control). "US" ultrasound-guided biopsies/ablations with or without "CT" computed tomography- imaging will be used to complete the procedures in either the CT suite or a procedure room, at the discretion of the physician, and according to normal local practice patterns.
Read the 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.
- Conditions
- Biopsy or Ablation Procedures
- Keywords
- biopsy guidance, tracking device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Registration Error
"TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))
Measured: Day 1
Secondary outcomes (1)
Success of ablation as determined by imaging
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startApr 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biopsy or Ablation ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279148
- Sponsor's protocol ID
- 2010 MCT V7
- Status last verified
- Apr 2021
- First submitted
- 10 Jan 2011
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Tracking of Devices During Interventional Procedures
- ClinicalTrials.gov ID
- NCT01279148
- Acronym / sponsor ID
- 2010 MCT V7
- Conditions
- Biopsy or Ablation Procedures
- Keywords
- biopsy guidance, tracking device
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, randomized, controlled, parallel-design trial will compare the use of electromagnetic tracking and image guidance during biopsy/ablation procedures verses the typical standard or conventional image guided procedure alone (control). "US" ultrasound-guided biopsies/ablations with or without "CT" computed tomography- imaging will be used to complete the procedures in either the CT suite or a procedure room, at the discretion of the physician, and according to normal local practice patterns.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitals and Out-patient Clinics
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target Registration Error
Time frame: Day 1
"TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))
1 secondary outcome
Success of ablation as determined by imaging
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biopsy or Ablation Procedures, run by Philips Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Registration Error (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021; AzTrials last refreshed its copy on 31 Oct 2026.