NCT07660900

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Sep 2025Dec 2027

Study Start

First participant enrolled

September 5, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 22, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 2, 2026

Last Update Submit

June 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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 Outcomes (1)

  • Instrument Tip Forces

    From robot docking to robot undocking during surgical procedure

Study Arms (2)

da Vinci 5 Robotic Surgical System

da Vinci Xi Robotic Surgical System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The James Cancer Hospital

Columbus, Ohio, 43221, United States

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 2, 2026

First Posted

June 22, 2026

Study Start

September 5, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 22, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations