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NCT Number: NCT06879912

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

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.

Recruiting

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To assess the force imparted on the tissue by force feedback instruments.

    Time frame: Intra-operative

Secondary outcomes

  1. To evaluate the utility of force feedback instruments during specific procedural steps or tasks.

    Time frame: Post-operative prior to discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Manish Bharara

CONTACT

[email protected]

Smruthi Srinivasa Murthy

CONTACT

[email protected]

682-552-6131

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

A Prospective, Post-Market Study to Evaluate the Clinical Utility of the Force Feedback Instruments in RAS Procedures Using the da Vinci 5 Surgical System

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2025
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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