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.

Study Overview

• Status: Recruiting
• Conditions: Lobectomy; Segmentectomy; Force Measurement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 270

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Recruiting
      • The James Cancer Hospital
      • Principal Investigator: Peter Kneuertz, MD
      • Contact: Chandler Lowe; Phone Number: 614-293-9955; Email: chandler.lowe@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants in this research will include individuals ages 18 years or older who are undergoing robotic-assisted anatomic lung resection (lobectomy or segmentectomy) at The Ohio State University Wexner Medical Center (OSUMC).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
da Vinci 5 Robotic Surgical System
da Vinci Xi Robotic Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Textbook Recovery	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.	From surgery date to 30 days post-operative

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Opioid Consumption	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
Post-Operative Pain Scores	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
Percutaneous drainage/output from chest tube in milliliters (mL)	At 24 hours and 48 hours post chest tube insertion
Length of Chest Tube Duration	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instrument Tip Forces	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.	From robot docking to robot undocking during surgical procedure

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY20250072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes