Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01401777 |
| Other study ID # |
2010_CRYO_V7 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2014 |
| Est. completion date |
December 2015 |
Study information
| Verified date |
April 2021 |
| Source |
Philips Healthcare |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The objective of this study is to assess and quantify any differences between assisted (using
real-time visualization of tracked cryo-probes) and unassisted cryoablation procedures using
pre-procedure CT scans or CT fluoroscopy with respect to:
Primary Endpoint:
• "TRE" Target Registration Error (distance between "virtual" needle position (tracking data)
and the actual needle position (CT confirmation scan))
Secondary Endpoints
- Accuracy of needle targeting - The vector of each needle insertion (The initial vector
allows us to project the path to the pre-defined target. If the initial entry point is
not ideal, the path to the target will need adjustment) Based on a two-sample t-test
(significance level of 0.05, two-tailed), the study has 89% power to detect a difference
of 2mm in accuracy between the two treatment groups (assuming a standard deviation of
1.9mm).
- Measure time difference between assisted and unassisted procedure
Description:
The objective of this study is to assess and quantify any differences between assisted (using
real-time visualization of tracked cryo-probes) and unassisted cryoablation procedures using
pre-procedure CT scans or CT fluoroscopy. To assess this, physicians will perform ablation
procedures with and without the Percu Nav device. Data will be collected on the angle of
needle entry unassisted and then assisted by PercuNAv to determine if the added imaging
information modifies the physician's needle approach.
Each patient will have a pre-procedure CT image set of the area of interest acquired. The
patient will be scanned in the same position that the ablation will be performed in, although
not requisite. Sterile registration patches will be applied to the patient's skin around the
area of interest prior to the scan, ensuring that suitable windows are left available for
needle entry. The patient will undergo these pre-procedural scans as part of the usual
clinical evaluation of the lesion to undergo ablation. The scans may be acquired with or
without contrast, at the discretion of the physician.
Control group: The physician will perform the procedure using the standard of care method (CT
only), without the additional information being recorded by the PercuNav device. 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. At the end of the procedure a verification CT scan will be taken with
the needle in place and sent to the PercuNav.
Percu Nav group: The physician will perform the procedure using the standard of care
procedure with the additional information displayed and recorded by the PercuNav device (CT
and PercuNav). 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 be 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 a verification CT scan will be taken (as is part of the regular standard of care
procedure) with the needle in place and sent to the PercuNav.
The outcome measures that will be evaluated in the groups include:
1. Accuracy - The distance between the "virtual" needle position (tracking data) and the
actual needle position (CT confirmation scan)), where applicable (TRE)
2. Time to reach a clinically acceptable target in the tumor
3. The total procedure time
4. Accuracy of needle targeting - The vector of each needle insertion (The initial vector
allows us to project the path to the pre-defined target. If the initial entry point is
not ideal, the path to the target will need adjustment)
