SP Thoracic IDE Study
A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary and Lobectomy for Benign and Malignant Disease
1 other identifier
interventional
32
1 country
6
Brief Summary
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
6 active sites
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
First Submitted
Initial submission to the registry
November 24, 2021
CompletedFirst Posted
Study publicly available on registry
December 9, 2021
CompletedStudy Start
First participant enrolled
July 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2023
CompletedResults Posted
Study results publicly available
December 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
ExpectedDecember 23, 2025
September 1, 2025
11 months
November 24, 2021
March 27, 2025
December 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of Conversion
Performance defined as the ability to complete the planned da Vinci SP-assisted pulmonary lobectomy and thymectomy procedures without conversion to an alternate approach
Intra-operative period
Major Adverse Event Rate
Safety defined as the incidence of major intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
Intra-operative through the 30 days follow-up period
Study Arms (2)
SP Surgical System- Lobectomy procedures
EXPERIMENTALPulmonary lobectomy performed by da Vinci SP Surgical System.
SP Surgical System - Thymectomy
EXPERIMENTALThymectomy procedures performed by the da Vinci SP Surgical System
Interventions
da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.
Eligibility Criteria
You may qualify if:
- Age \> 21 years
- BMI ≤ 35
- ASA ≤ 3
- Willing and able to provide a written informed consent
- Willing and able to comply with the study protocol requirements including follow-up examinations at 14 days and 30 days post-operatively, and post-market long term follow-up on an annual basis through 5 years
- \- Clinical stage I or II primary lung cancer or other suspected lung malignancy; or benign lung disease requiring resection; primary tumor ≤ 5cm diameter
- \- Masaoka clinical stage I or II thymoma; or thymectomy for myasthenia gravis; thymic mass ≤ 5 cm diameter
You may not qualify if:
- Clinical or radiological evidence of mediastinal or systemic metastatic disease
- Life expectancy \< 6 months
- Subject with a known bleeding or clotting disorder
- Subjects actively receiving therapeutic-dose anticoagulation or anti-platelet medications at the time of operation
- Uncontrolled systemic illness 6 months prior to planned surgical procedure including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Previous chemotherapy, immunotherapy and/or radiation therapy for treatment of the cancer to be resected
- Subject has a contraindication for general anesthesia or surgery
- Subjects under active immunomodulatory or immunosuppressive regimen (e.g. transplant patient, high-dose steroid requirement) within 30 days prior to the planned surgical procedure. For myasthenia patients, if steroids are weaned down to prednisone ≤ 5 mg/day prior to day of surgery, the patient may be enrolled
- Previous sternotomy
- Subject belongs to vulnerable population
- Subject is pregnant or suspected to be pregnant or breastfeeding
- Tumor involving carina or any airway requiring sleeve resection, bronchoplasty
- Tumor requiring resection of local structures (e.g. chest wall) or extended resection such as bilobectomy
- History of pulmonary hypertension
- Previous ipsilateral thoracic surgery or radiotherapy
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NYU Langone Health
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Zervos M, Park BJ, Marshall MB, Wee JO, Soukiasian HJ, Hartwig MG, Rajaram R, Rice DC. Robotic-assisted single-port system for pulmonary lobectomy: A prospective feasibility study. J Thorac Cardiovasc Surg. 2025 Jul;170(1):54-60.e1. doi: 10.1016/j.jtcvs.2025.04.004. Epub 2025 Apr 9.
PMID: 40216299DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anna Virk
- Organization
- Intuitive
Study Officials
- PRINCIPAL INVESTIGATOR
David Rice, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2021
First Posted
December 9, 2021
Study Start
July 20, 2022
Primary Completion
June 16, 2023
Study Completion (Estimated)
July 1, 2028
Last Updated
December 23, 2025
Results First Posted
December 23, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share