Clinical trial NCT01040884: Safety And Accuracy Study Of The Actisight™ Needle Guidance System In Patients Undergoing CT-Guided Procedures
Official title: A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Preliminary Safety and Accuracy of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Aspiration, Biopsy and RF Ablations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Lead sponsor: ActiViews Ltd.
Sponsor class: INDUSTRY
First posted: 2009-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be a prospective, single-arm, single-center, open-label study to evaluate the preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided percutaneous aspiration and RF Ablations The procedure will be performed by a trained physician. Subjects will be screened for inclusion in the study. Following signing of informed consent, screening procedures will be performed including demographic and medical history, vital signs, anthropometrics), chest radiography, if applicable and CT scanning, blood samples for coagulation indices (PT, APTT), if applicable, and pregnancy test in women of child-bearing potential.

Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation utilizing the ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect chest radiograph will be performed within 90 minutes of observation after chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. \*\* Note \*\* If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.

Detailed description: Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation utilizing the ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect chest radiograph will be performed within 90 minutes of observation after chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. \*\* Note \*\* If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects, 18 years of age or older at the time of enrollment
* Subjects meeting all medical conditions for percutaneous aspiration/biopsy with safe path to lesion
* INR \<1.4
* Written informed consent to participate in the study
* Ability to comply with the requirements of the study procedures

Exclusion Criteria:

* Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
* Use of Aspirin or similar antithrombotic medication
* Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
* Subjects who cannot tolerate mild sedation
* Subjects with the following laboratory values, unless approved by hematologist:

  * Platelet count \< 60,000/mL
  * APTT \> 39 sec or PT \> 15 sec, INR \> 1.4
  * 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.
  * Subjects who are uncooperative or cannot follow instructions

Primary outcomes:
measure: Frequency of target reached (tip of the needle location) within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan
timeFrame: During procedure
Secondary outcomes:
measure: Number of needle punctures through the skin
timeFrame: During procedure
measure: Number of CT scans needed
timeFrame: During procedure
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: ActiViews Ltd
Study officials:
affiliation: Hadassah Ein Carem
name: Liat Appelbaum, Dr.
role: PRINCIPAL_INVESTIGATOR
References: