Clinical trial · Interventional
Data Collection in Patients Undergoing CT-Guided Needle Interventions for NeedleWays System Development
A Prospective Data Collection, Single-Center, Open Label Study in Patients Undergoing CT-Guided Needle Interventions for the Development of the NeedleWays System
NCT02329665CI-TRIAL-00016514unknownN/AClinicalTrials.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 primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System.
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 |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NeedleWays™ System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NeedleWays™ System
- description
- A total of 50 consecutive subjects scheduled for clinically indicated CT guided needle intervention procedure will be invited to enroll in the study.
- interventionNames
- Device: NeedleWays™ System
Primary outcomes (1)
- measure
- collect CT images of patients undergoing CT
- timeFrame
- procedure duration
- description
- The primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Male or female subjects, 18 years of age or older at the time of enrollment. * Subjects meeting all medical conditions for percutaneous CT-guided needle intervention. * INR \<1.4 * Written informed consent to participate in the study. * Ability to comply with the requirements of the study procedures. Exclusion Criteria * Subjects diagnosed with one or more of the following according to medical records: * Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting,Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia * Subjects treated with Ticlopidine or similar antithrombotic medication. * Subjects who cannot tolerate mild sedation * Subjects with the following laboratory values, unless otherwise approved by hematologist: * Platelet count \<60,000/ml * APTT \>39 sec or PT \>15 sec * Pregnancy or lactation * Subject is unable to comply with requirements of the procedure, i.e. holding breath. * Subject participation in an investigational trial within 30 days of enrollment * Subjects who are uncooperative or cannot follow instructions
References
Publications (0)
Data not yet available
No reference posted for this study.