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

June 16, 2026 updated by: Peter Kneuertz, Ohio State University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • The James Cancer Hospital
        • Principal Investigator:
          • Peter Kneuertz, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
da Vinci 5 Robotic Surgical System
da Vinci Xi Robotic Surgical System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From surgery date to 30 days post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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)
Time Frame: At 24 hours and 48 hours post chest tube insertion
At 24 hours and 48 hours post chest tube insertion
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
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From robot docking to robot undocking during surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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