SP Thoracic IDE Study

Study summary

To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedRobotic-Assisted Surgery

The study team can explain what participation involves.

Who it may be forPrimary Lung Cancer · Benign Lung Disease

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 14, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Intuitive Surgical

Study sponsor

Study overview

What this study is about

Purpose: Other
Study type: Interventional
Phase: Not applicable
Sponsor: Intuitive Surgical
Interventions being studied: Device: Robotic-Assisted Surgery

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Surgery→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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 Lobectomy Inclusion Criteria: \- Clinical stage I or II primary lung cancer or other suspected lung malignancy; or benign lung disease requiring resection; primary tumor ≤ 5cm diameter Thymectomy Inclusion Criteria: \- Masaoka clinical stage I or II thymoma; or thymectomy for myasthenia gravis; thymic mass ≤ 5 cm diameter

Reasons someone may not be able to joinExclusion criteria

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 Lobectomy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Cedars-Sinai Medical CenterLos Angeles, California
Brigham and Women's HospitalBoston, Massachusetts
NYU Langone HealthNew York, New York
Memorial Sloan Kettering Cancer CenterNew York, New York
Duke University HospitalDurham, North Carolina
MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 14, 2026. Always confirm current availability with the study team.

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