Clinical trial · Observational
Electromagnetic Tracking of Devices During Biopsy Procedures
NCT01403727CI-TRIAL-00010444completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the trial is to evaluate the differences between PercuNav assisted and unassisted biopsy in the areas of CT radiation dose, procedure time and biopsy accuracy. This prospective, randomized, controlled trial will compare the use of electromagnetic tracking and image guidance (CT) during biopsy procedures verses the typical CT image guided procedure alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Tumors | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Unassisted Biopsy - CONTROL GROUP
- description
- Routine biopsy needle placement and Physician blinded to needle location
- label
- Assisted Biopsy - STUDY GROUP
- description
- The physician will be shown the PercuNav screen and will correct the desired approach path.
Primary outcomes (1)
- measure
- Radiation Dose
- timeFrame
- 24 hrs
- description
- The primary objective of this study is to assess and quantify any differences between assisted and unassisted CT guided biopsy procedures of the liver with respect to radiation dose.
Secondary outcomes (2)
- measure
- Total procedure time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has had a pre-operative CT scan performed and will be undergoing a biopsy procedure of the liver; 2. Is over the age of 18; 3. Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol; 4. Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure. Exclusion Criteria: 1. Was precluded from a biopsy procedure based on standard exclusions; 2. Has an adhesive allergy (due to the application of active fiducials with adhesive backing); 3. Has a pacemaker or automatic implantable cardiac defibrillator; 4. Has a gross body weight above 180lbs for women and 260lbs for men; 5. Is pregnant A patient may be excluded after enrollment if any of the following criteria are met: 1\. The patient's health and/or safety become jeopardized for any reason making it unsafe to continue; 2. Technical errors and/or difficulties; 3. Any reasonable rationale put forth by the physician or investigator 4. Lost to follow up - In-evaluable data \-
References
Publications (0)
Data not yet available
No reference posted for this study.