An interventional study of Robotic-Assisted Surgery in Primary Lung Cancer, Benign Lung Disease and Thymoma, sponsored by Intuitive Surgical. Active, not recruiting at 6 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Intuitive Surgical · Not applicable, Interventional, and Other
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
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.
133 studies on the registry are indexed under Thymoma; 37 are open to participants now.
This study's enrollment of 32 is below the median of 44 across 108 interventional studies indexed under Thymoma.
Browse Thymoma studies →Intuitive Surgical is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Lobectomy Inclusion Criteria:
- Clinical stage I or II primary lung cancer or other suspected lung ; 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
Exclusion Criteria:
Lobectomy Exclusion Criteria:
Thymectomy Exclusion Criteria:
Intraoperative Exclusion Criteria:
- Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pulmonary lobectomy performed by da Vinci SP Surgical System.
Device: Robotic-Assisted Surgery
Thymectomy procedures performed by the da Vinci SP Surgical System
Device: Robotic-Assisted Surgery
da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.
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
Time frame: 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.
Time frame: Intra-operative through the 30 days follow-up period
| Milestone | SP Surgical System -Thymectomy | SP Surgical System - Lobectomy |
|---|---|---|
| Started | 13 | 19 |
| Completed | 13 | 19 |
| Not completed | 0 | 0 |
Performance defined as the ability to complete the planned da Vinci SP-assisted pulmonary lobectomy and thymectomy procedures without conversion to an alternate approach
| Participants | SP Surgical System- Thymectomy Arm | SP Surgical System - Lobectomy Arm |
|---|---|---|
| Rate of Conversion | 0 | 0 |
Safety defined as the incidence of major intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
| Participants | SP Surgical System- Thymectomy Arm | SP Surgical System - Lobectomy Arm |
|---|---|---|
| Major Adverse Event Rate | 0 | 3 |
Collected over Through the 30 day follow up period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SP Surgical System- Thymectomy | 0/13 (0%) | 0/13 (0%) | 5/32 (15.6%) |
| SP Surgical System- Pulmonary Lobectomy | 0/19 (0%) | 4/19 (21.1%) | 5/19 (26.3%) |
| Event | SP Surgical System- Thymectomy | SP Surgical System- Pulmonary Lobectomy |
|---|---|---|
| Air LeakageRespiratory, thoracic and mediastinal disorders | 0/13 | 3/19 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 0/13 | 1/19 |
| Event | SP Surgical System- Thymectomy | SP Surgical System- Pulmonary Lobectomy |
|---|---|---|
| Non-serious AEGeneral disorders | 5/32 | 5/19 |
| Intraoperative Adverse EventRespiratory, thoracic and mediastinal disorders | 0/32 | 0/19 |
| Age, Continuous(years) | SP Surgical System - Thymectomy | SP Surgical System - Lobectomy | Total |
|---|---|---|---|
| Thymectomy | 54.5 ± 15.86 | — | 54.5 ± 15.86 |
| Lobectomy | — | 66.4 ± 8.06 | 66.4 ± 8.06 |
| Sex: Female, Male(Participants) | SP Surgical System - Thymectomy | SP Surgical System - Lobectomy | Total |
|---|---|---|---|
| Female | 11 | 6 | 17 |
| Male | 2 | 13 | 15 |
| Race (NIH/OMB)(Participants) | SP Surgical System - Thymectomy | SP Surgical System - Lobectomy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 6 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 7 | 12 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2022 to primary completion in Jun 2023, 10 months.
Results were first posted in Dec 2025, 2 years 6 months after primary completion.
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