A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot

Launched by INTUITIVE SURGICAL · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial aims to explore how helpful force feedback instruments are during surgeries performed with the da Vinci 5 robotic system. This type of technology could improve the way surgeons operate on conditions like hernias, colorectal issues, and gynecologic problems. The study is observational, meaning researchers will observe and gather information without changing the way surgeries are done.

To be eligible for this study, participants must be at least 22 years old and have a planned robotic surgery using the da Vinci 5 robot with the specific instruments being tested. It's important that participants are in good enough health to undergo surgery and can provide consent for the study. Those who are currently experiencing emergencies, have certain medical conditions, or are pregnant may not qualify. If you join the study, you can expect to follow a protocol that includes scheduled check-ups after your surgery. Remember, this trial is not yet recruiting participants, so there will be more information available soon for those interested in taking part.

Gender

ALL

Eligibility criteria

• Pre-Operative Inclusion Criteria:
• • 1. Age 22 years or older
• • 2. ASA ≤ 3
• • 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
• • 4. Subject or a legally authorized representative is able to provide written informed consent using the study informed consent form prior to the study
• • 5. 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.