IIT of needle insertion robot

JRCT ID: jRCT2062200013

Registered date:11/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lesions located in trunk or limbs(cohot 1), liver cancer and renal cancer(cohot 2)
• Date of first enrollment: 25/08/2020
• Target sample size: 27
• Study type: Interventional
• Intervention(s): Needle insertion using unapproved medical device

Outcome(s)

• Primary Outcome: Needle insertion accuracy for CT-guided percutaneous needle biopsy evaluated by core evaluation committee

Secondary Outcome

(a) Cohort 1.
(1) Technical success
(2) Histopathological findings.
(3) Radiation exposure to subjects during needle insertion (tube current time product, DLP)
(4) Radiation exposure to subjects during the entire procedure (tube current time product, DLP)
(5) Effective dose to the operator during needle insertion
(6) Effective dose to the operator during the entire procedure
(7) Time during using on CT fluoroscopy for needle insertion
(8) Needle insertion time (time from start to finish using CT fluoroscopy)
(9) Entire procedure time (time from the start of the first CT scan to the end of the last CT scan)
(10) Number of needle insertion

(b) Cohort 2.
(1) Needle insertion accuracy for percutaneous CT fluoroscopy-guided ablation
(2) Technical success.
(3) Technique efficacy
(4) Radiation exposure to subjects during needle insertion (tube current time product, DLP) in first sesssion with first needle
(5) Radiation exposure to subjects during the entire procedure (tube current time product, DLP)
(6) Effective dose to the operator during needle insertion in first sesssion with first needle
(7) Effective dose to the operator during the entire procedure
(8) Time during using on CT fluoroscopy for needle insertion in first sesssion with first needle
(9) Needle insertion time (time from start to finish using CT fluoroscopy) in first sesssion with first needle
(10) Entire procedure time (time from the start of the first CT scan to the end of the last CT scan)
(11) Number of needle insertion in first sesssion with first needle

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Ensure that all of the following selection criteria are met in the period between obtaining consent and registration
(a) Cohorts 1 and 2 common
(1) Age at the time of obtaining consent of 20 years old or older
(2) Platelet count of 50,000/microlitter or more
(3) PT-INR of less than 1.5
(4) Single target lesion for the procedure

(b) Cohort 1 only.
(5) Patients with limb or trunk lesions indicated for percutaneous biopsy

(c) Cohort 2 only.
(6) Patients with liver cancer and renal cancer indicated for percutaneous ablation

Exclude criteria

In the period between obtaining consent and registration, ensure that any of the following exclusion criteria are not met

(a) Cohorts 1 and 2 common
(1) Inability to restrict body movement or breath hold as instructed by the operator
(2) Patients who take antiplatelet or anticoagulant medication, and it is judged that the medication cannot be discontinued despite that medication is necessary for the procedure according to the rules of the Department of Radiology at Okayama University Hospital.
(3) The organ or structure at risk for insertion (heart/large vessels, gastrointestinal tract, pancreas, etc.) is within 10 mm of the scheduled needle tract (a straight line from skin entry point to the target point).
(4) The target lesion of less than 10 mm in long-axis diameter.
(5) Inability to set needle tract avoiding bony tissue
(6) Pregnant patients.
(7) Patients who are enrolled in other clinical trials
(8) Patients who are judged to be inappropriate as the subject of this study by the investigator

(b) Cohort 1 only.
(9) Targeted lesions in the spinal cord, heart/large vessels, and gastrointestinal tract

(c) Cohort 2 only.
(10) Child-Pugh classification C
(11) massive ascites
(12) Uncontrolled malignancy at a site other than the liver or kidneys
(13) Wearing an implantable cardiac pacemaker or automatic implantable cardioverter defibrillator
(14) Scheduled other treatments (radiotherapy, hepatic arterial embolization, hepatic arterial infusion of chemotherapy, molecular targeted drugs, liver resection, liver transplantation, kidney resection, kidney transplantation) within 1 month after ablation for the target lesion.
(15) Inability to perform contrast-enhanced CT due to allergy to iodine, etc.

Related Information

• Primary Sponsor: Hiraki Takao
• Source(s) of Monetary Support: Japan Agency for Medical Reserch and Development