Overview
The goal of this observational study is to understand the utility of force feedback instruments in surgeries that are done using the da Vinci 5 robot.
Eligibility
Pre-Operative Inclusion Criteria:
- Age 22 years or older
- ASA ≤ 3
- The clinical decision has been made to perform multi-port robotic assisted surgery with da Vinci 5 with Force Feedback instruments for the study specified procedure as primary procedure prior to enrollment in the study
- Subject or a legally authorized representative is able to provide written informed consent using the study informed consent form prior to the study
- Subject is willing and able to comply with the study protocol requirements including follow up schedule
Pre-operative Exclusion Criteria:
- Subject receiving an emergent procedure
- Subject planned to undergo major concomitant surgery for the treatment of a different medical condition than was originally planned
- Subject with previous ipsilateral surgery (open, endoscopic or robotic) with the same surgical indication
- Subject with past or ongoing medical conditions (for example: inflammatory bowel disease) which, in the judgment of the Investigator, puts them at high risk for surgery and not appropriate for the study
- Subject is pregnant or suspected to be pregnant or breastfeeding
- Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data
- Subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months
- Subject belongs to a vulnerable population.
- Subject is contraindicated for anesthesia or surgery.
- Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for the treatment of the cancer to be resected within the past 6 months
Intra-operative Exclusion Criteria
- Subject with hemodynamic or respiratory instability, which precludes the Investigator from performing the RAS.
- Subject in whom inadequate visualization makes a minimally invasive approach not feasible, as determined from the investigator assessment prior to docking the robot.
- Subject with adhesions, scarring and disease status in the body which in the opinion of the investigator limits the ability to perform the minimally invasive procedure.