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Electromagnetic Tracking of Devices During Interventional Procedures - A Cryoablation Study

NCT01401777 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-04-27

No results posted yet for this study

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

Conditions

  • Kidney Tumors

Sponsors & Collaborators

  • Philips Healthcare

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-05-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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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 NCT01401777 on ClinicalTrials.gov