Clinical trial · Interventional
A Percutaneous Ultrasound Device With Needle Guide for Vascular Access
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Expired IRB status
Summary
Brief summary (as posted)
This first-in-human pilot study seeks to evaluate the feasibility and safety of using a percutaneous ultrasound device with needle guide for vascular access. Eligible participants will undergo the procedure of transcatheter arterial chemoembolization for primary or metastatic liver cancer, as part of participants' clinical care. The percutaneous ultrasound device with needle guide will be deployed in eligible participants at the beginning of the procedure for guiding a needle inside the femoral artery. Once the needle is inside the artery, then a guide wire is advanced inside the needle and vascular access is successfully obtained. The study will identify whether this ultrasound-based device with needle guide is helpful for guiding a needle inside the femoral artery.
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 |
|---|---|---|---|
| Vascular Access | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vu-Path™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Device Arm
- description
- Study participants will be enrolled in the Device Arm and the Vu-Path™ Device will be used to access the femoral artery for intra-arterial chemoembolization.
- interventionNames
- Device: Vu-Path™
Primary outcomes (2)
- measure
- Device Safety as assessed by number of participants with Minor Bleeding
- timeFrame
- Within 24 hours from intervention
- description
- Device Safety will be assessed by the number of participants experiencing minor bleeding resulting from vascular puncture. Minor bleeding is defined as either a) bleeding that requires no therapy, or has no consequences or, b) requires nominal therapy, or has no consequence or, c) includes overnight admission for observation only.
- measure
- Device Safety as assessed by number of participants with Major Bleeding
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female participants, 18 years of age or older at the time of enrollment. * Participants meeting all medical conditions for percutaneous angiography. * International Normalized Ratio (INR) \<1.3. * Written informed consent to participate in the study. * Ability to comply with the requirements of the study procedures. Exclusion Criteria: * Fibrous tissue in access path. * Active skin infection at the point of needle insertion. * Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting * Use of antithrombotic medication. * For participants taking warfarin or other anticoagulant medication, INR \>1.3. * Participants who cannot tolerate mild sedation. * Participants with the following laboratory values, unless approved by hematologist: Platelet count \<100,000/mL, Activated Partial Thromboplastin Time (APTT) \>39 sec or Prothrombin Time (PT) \>15 sec * Pregnancy or lactation * Patient is unable to comply with requirements of the procedure, i.e. holding breath * Participation in an investigational trial within 30 days of enrollment. * Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition that could, in the opinion of the investigator, of interfering with the conduct of the study. * Participants who are uncooperative or cannot follow instructions.
References
Publications (0)
Data not yet available