Actively Recruiting
A Prospective, Post-Market Study to Evaluate the Clinical Utility of the Force Feedback Instruments in Robotic-Assisted Surgery Using the da Vinci 5 Surgical System
Led by Intuitive Surgical · Updated on 2026-02-25
200
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study aims to understand how force feedback instruments are useful during surgeries performed with the da Vinci 5 robotic system. It focuses on procedures such as inguinal and ventral hernia repairs, colorectal, thoracic, gynecologic surgeries, and partial nephrectomy. The study is designed to gather information on how these instruments perform during robotic-assisted surgery. Participants will undergo multi-port robotic-assisted surgery using the da Vinci 5 system equipped with force feedback instruments, which provide tactile sensations. The study observes surgeries planned as primary procedures with these instruments, without altering the treatment. There is no experimental drug or placebo involved, as this is an observational study conducted after the devices have been marketed. During the study, researchers will measure the force applied to tissues by the force feedback instruments during surgery and evaluate how useful these instruments are during specific steps of the procedure before patient discharge. Participants will be followed up as per the study protocol to ensure data quality. The total participation time varies depending on the surgical procedure and follow-up schedule.
CONDITIONS
Brief Title
A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- ASA (American Society of Anesthesiologists) score of 3 or less
- Planned multi-port robotic assisted surgery with da Vinci 5 using force feedback instruments as the primary procedure
- Ability to provide written informed consent before the study
- Willingness and ability to follow study protocol and attend follow-up visits
You will not qualify if you...
- Receiving an emergent surgical procedure
- Planned major additional surgery for a different medical condition
- Previous surgery on the same side for the same indication
- Medical conditions putting the participant at high risk for surgery (e.g., inflammatory bowel disease), as determined by the investigator
- Pregnant, suspected pregnancy, or breastfeeding
- Any condition that may interfere with data collection quality
- Participation in another investigational drug or high-risk device study within the past 6 months
- Belonging to a vulnerable population
- Contraindications for anesthesia or surgery
- Previous neoadjuvant therapy, chemotherapy, immunotherapy, or radiation for the cancer to be resected within the past 6 months
- Hemodynamic or respiratory instability preventing robotic surgery
- Inadequate visualization making minimally invasive surgery not feasible
- Adhesions, scarring, or disease status limiting the ability to perform minimally invasive surgery, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo planned multi-port robotic assisted surgery with da Vinci 5 using force feedback instruments. Intra-operative assessments are performed to evaluate the force imparted on tissue by the instruments.
1 visit (in-person)
Duration - Until discharge
Participants are observed post-operatively prior to discharge to evaluate the utility of force feedback instruments during specific procedural steps or tasks.
Approximately 1 to 2 visits (in-person) prior to discharge
Trial Site Locations
Total: 5 locations
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
2
Northeast Georgia Medical Center, Inc
Gainesville, Georgia, United States, 30501
Actively Recruiting
3
Northwestern Memorial Healthcare
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
5
St. David's Healthcare
Austin, Texas, United States, 78758
Actively Recruiting
Research Team
S
Smruthi Srinivasa Murthy
M
Manish Bharara
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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