Clinical trial · Interventional
The Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided With Lesions Smaller Than 15 mm
A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy With Lesions Smaller Than 15 mm
- 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)
This will be a prospective, single-arm, single-center, open-label study to evaluate the use of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm undergoing CT-guided percutaneous chest aspiration. Target location will be in the chest area; the procedure will be performed by a trained physician.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ActiSight™ Needle Guidance System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ActiSight™ Needle Guidance System
- description
- ActiSight™ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera.
- interventionNames
- Device: ActiSight™ Needle Guidance System
Primary outcomes (1)
- measure
- Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
- timeFrame
- 6 month
- description
- Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
Secondary outcomes (5)
- measure
- Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images
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 scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures * Subjects with lung lesions less than 15 mm. * Written informed consent to participate in the study * Ability to comply with the requirements of the study procedures Exclusion Criteria: * Subjects who cannot tolerate mild sedation * Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment. * Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study. * Subjects who are uncooperative or cannot follow instructions
References
Publications (0)
Data not yet available