Health Condition 1: N398- Other specified disorders of urinary system
Conditions
Interventions
Intervention1: The Mendaera Guidance System: This is a Robotic Instrument Guidance System to Perform Safe Ultrasound-Guided Percutaneous Procedures.
This robotic device is intended to provide guidance
Sponsors
Mendaera, Inc.
Eligibility
Inclusion criteria
Inclusion criteria: Patients for whom an ultrasound guided percutaneous procedure is indicated including: For all procedures: Age greater than or equal to 18 years Subject or legal representative is willing and able to provide informed consent Subject is willing and able to comply with protocol follow-up Elective procedure (non-emergent) Organ access procedures (at least one of the following): Subjects for whom a percutaneous renal access for nephrostomy tube placement or percutaneous Patients for whom an ultrasound guided percutaneous procedure is indicated including: For all procedures: Age greater than or equal to 18 years Subject or legal representative is willing and able to provide informed consent Subject is willing and able to comply with protocol follow-up Elective procedure (non-emergent) Organ access procedures (at least one of the following): Subjects for whom a percutaneous renal access for nephrostomy tube placement or percutaneous nephrolithotomy have has been indicated. Subjects for whom a percutaneous biopsy have has been indicated Subjects for whom a percutaneous drainage (e.g. paracentesis, thoracentesis, etc.) have has been indicated Vascular access procedures Subjects for whom a vascular access (arterial or venous) have been indicated Pain management injection procedures Subjects for whom a pain management injection procedure has been indicated, such as intra-articular injection, nerve block pre- or postoperatively, and epidural
Exclusion criteria
Exclusion criteria: Among patients indicated for an ultrasound guided percutaneous procedure: For all procedures Patient refusal Patient is unstable or potentially unstable Known significant coagulopathy, defined as International Normalized Ratio greater than two point zero and platelet count less than one hundred thousand per microliter Previous failed attempt of the same procedure Suspected infection at the intended needle insertion site or target site Body mass index greater than thirty five kilogram per meter square Subject has any other medical, social, or psychological problem that, in the opinion of the Investigator, precludes them from participating Subject who is pregnant or intends to become pregnant during the studyHypertension, defined as subject blood pressure greater than or equal to one hundred eighty over one hundred ten millimeter of mercury History of venous thrombosis Organ access procedures Known anatomic abnormalities of the target organ Patient underwent transplant or urinary diversion Abnormal kidney function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective for the study is to assess the safety and technical feasibility of using a robotic instrument guidance system to place instruments during ultrasound-guided percutaneous procedures.Timepoint: As this is a safety and feasibility study of Robotic Instrument Guidance System, Time points are not applicable. Total expected duration of each subject s participation will be no more than 24 12 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study is to collect data that begins to characterize the clinical performance of the system, & user experience with the system.Timepoint: As this is a safety & feasibility study of Robotic Instrument Guidance System, Time points are not applicable. Total expected duration of each subject s participation will be no more than 24 12 hours. | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research
Outcome results
None listed