Primary Lung CancerNCT05150210
SP Thoracic IDE Study
A study testing Robotic-Assisted Surgery in people with Primary Lung Cancer and Benign Lung Disease, run by Intuitive Surgical at 6 sites in United States.
Trial summary
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Primary Lung Cancer, Benign Lung Disease, Thymoma
- What is being tested?
- Robotic-Assisted Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Jul 2022to Jul 2028
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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 Exclusion Criteria:
- 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
- Thymectomy Exclusion Criteria:
- Uncontrolled myasthenia gravis symptoms at the time of scheduled surgery
- Tumor requiring resection of local structures (except pericardium)
- Confirmed thymic carcinoma
- Intraoperative Exclusion Criteria:
- Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Duke University Hospital
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
NYU Langone Health
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary and Lobectomy for Benign and Malignant Disease
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
Read the detailed description
Primary performance:
The primary endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted thoracic procedure without conversion to an alternate approach. Conversion to an alternate approach comprises undocking of the da Vinci SP to complete the planned procedures using other methods, such as open, VATS, or multiport robotic (da Vinci SI or X/Xi)
Primary Safety:
The primary safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
- Conditions
- Primary Lung Cancer, Benign Lung Disease, Thymoma, Myasthenia Gravis
- Being tested
- Robotic-Assisted Surgery
- Medical subject headings
- Thymoma, Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-Assisted SurgeryDevice
da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.
| Study group | Role | What they receive |
|---|---|---|
| SP Surgical System- Lobectomy procedures | Experimental | Pulmonary lobectomy performed by da Vinci SP Surgical System. Receives: Device: Robotic-Assisted Surgery |
| SP Surgical System - Thymectomy | Experimental | Thymectomy procedures performed by the da Vinci SP Surgical System Receives: Device: Robotic-Assisted Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Intra-operative through the 30 days follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start20 Jul 2022
- Primary completion16 Jun 2023
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Lung CancerStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Rice, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150210
- Sponsor's protocol ID
- SP Thoracic IDE
- Status last verified
- Sep 2025
- First submitted
- 24 Nov 2021
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40216299
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary and Lobectomy for Benign and Malignant Disease
- ClinicalTrials.gov ID
- NCT05150210
- Acronym / sponsor ID
- SP Thoracic IDE
- Conditions
- Primary Lung Cancer, Benign Lung Disease, Thymoma, Myasthenia Gravis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
Detailed description
Primary performance:
The primary endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted thoracic procedure without conversion to an alternate approach. Conversion to an alternate approach comprises undocking of the da Vinci SP to complete the planned procedures using other methods, such as open, VATS, or multiport robotic (da Vinci SI or X/Xi)
Primary Safety:
The primary safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP Surgical System- Lobectomy procedures | Experimental | Device: Robotic-Assisted SurgeryPulmonary lobectomy performed by da Vinci SP Surgical System. |
| SP Surgical System - Thymectomy | Experimental | Device: Robotic-Assisted SurgeryThymectomy procedures performed by the da Vinci SP Surgical System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-Assisted Surgeryda Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease. | Device | SP Surgical System - Thymectomy, SP Surgical System- Lobectomy procedures |
Primary outcome
Rate of Conversion
Time frame: Intra-operative period
Performance defined as the ability to complete the planned da Vinci SP-assisted pulmonary lobectomy and thymectomy procedures without conversion to an alternate approach
Major Adverse Event Rate
Time frame: Intra-operative through the 30 days follow-up period
Safety defined as the incidence of major intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40216299Zervos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rice, MD principal investigator
M.D. Anderson Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-Assisted Surgery in people with Primary Lung Cancer and Benign Lung Disease, run by Intuitive Surgical at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Conversion (time frame: Intra-operative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.