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NCT Number: NCT07660900

Evaluating the Association of Force Feedback With Outcomes After Lung Resection Using the da Vinci Multiport System

The purpose of this research is to study patient outcomes based on the use of Force Feedback instruments during robotic-assisted lung resection. Force Feedback technology describes the physical forces a surgeon senses when pushing and pulling structures inside the body during robotic-assisted surgery.

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Key information

Conditions

Lobectomy Force Measurement Segmentectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The James Cancer Hospital

Columbus, Ohio, 43221, United States

Location status: Recruiting

Location contact

Chandler Lowe

CONTACT

[email protected]

614-293-9955

Peter Kneuertz, MD

PRINCIPAL_INVESTIGATOR

About this study

The objective of the proposed study is to evaluate whether reduced force applied at the tips of Force Feedback instruments is associated with improvements in outcomes following robotic-assisted anatomic lung resections. The investigators propose a prospective cohort study of patients undergoing anatomic lung resection at a single high volume thoracic surgery institution to analyze outcomes based on the use of Force Feedback instruments. Investigators will use a composite endpoint of textbook recovery to capture patients who have an uncomplicated postsurgical trajectory with absence of complication, early discharge, and absence of readmission. The insights gained from this study will help surgeons understand the implications of force applied during thoracic surgical procedures and establishing the value of Force Feedback instruments. The investigators hypothesize that the use of Force Feedback instruments will result in an increase in the rate of early hospital discharge (length of stay less than 3 days) in patients undergoing robotic-assisted anatomic lung resections.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages 18 years or older
  • Undergoing robotic-assisted anatomic lung resection (lobectomy or segmentectomy) at The Ohio State University Wexner Medical Center

Exclusion criteria

  • Age < 18 years old
  • Subject is pregnant or suspected to be pregnant or breastfeeding
  • ECOG Performance status > 2
  • Do not qualify for ERAS protocol
  • Undergoing an emergent procedure
  • Undergoing non-anatomic lung resection
  • Undergoing pneumonectomy
  • Previous ipsilateral thoracic surgery (open, video-assisted thoracoscopic or robotic)
  • Planned to undergo major concomitant surgery for the treatment of a different medical condition than was originally planned
  • Non-English speaking

Treatment and study plan

Primary outcomes

  1. Textbook Recovery

    Time frame: From surgery date to 30 days post-operative

    The primary endpoint will be the textbook recovery, which will be defined as chest tube removal within 48 hours post-surgery, based on absence of air leak, absence of major complications or mortality within 30 days, no chest tube reinsertion, no atrial fibrillation, early hospital discharge with length of stay <3 days, and absence of readmission. The rates of textbook recovery will be compared between patients undergoing anatomic lung resection with or without Force Feedback instruments.

Secondary outcomes

  1. Total Opioid Consumption

    Time frame: From admission to the hospital for robotic-assisted anatomic lung resection (lobectomy or segmentectomy) to discharge from the hospital, an average of 2 to 4 days

  2. Post-Operative Pain Scores

    Time frame: From admission to the hospital for robotic-assisted anatomic lung resection (lobectomy or segmentectomy) to discharge from the hospital, an average of 2 to 4 days

  3. Percutaneous drainage/output from chest tube in milliliters (mL)

    Time frame: At 24 hours and 48 hours post chest tube insertion

  4. Length of Chest Tube Duration

    Time frame: From admission to the hospital for robotic-assisted anatomic lung resection (lobectomy or segmentectomy) to discharge from the hospital, an average of 2 to 4 days

Other outcomes

  1. Instrument Tip Forces

    Time frame: From robot docking to robot undocking during surgical procedure

    Correlative endpoints will be instrument tip forces measured by the Force Feedback Instruments, including average and peak forces, time above 6.5N and overall work (cumulative force over time) for the overall case and for selected operative steps as determined by video segmentation. An exploratory analysis will be performed to test the associated between dV5 system instrument tip forces (average for the case and per tasks) with primary and secondary outcomes.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 22, 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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