Robot-Assisted surgery for lung cancer and thymus disease put to the test
NCT ID NCT05150210
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This study is testing a new robotic surgery system, the da Vinci SP, for removing part or all of a lung (lobectomy) or the thymus gland (thymectomy) in people with lung cancer, benign lung disease, thymoma, or myasthenia gravis. The goal is to see if the robot can perform these surgeries safely without needing to switch to a different method. Thirty-two adults will be enrolled and followed for 30 days after surgery, with long-term follow-up for up to 5 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- da Vinci SP Surgical System (robotic-assisted surgery device)
- What this could lead to
- If successful, this could show that the da Vinci SP robot is a safe and effective tool for minimally invasive lung and thymus surgeries.
- What could go wrong
- This is a small, early-stage study with only 32 participants, so results may not apply to everyone. There are always risks with surgery, such as complications or the need to switch to a different approach.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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32 people
The number who actually took part.
- Started
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Jul 2022
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 Exclusion 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Duke University Hospital
Durham, North Carolina, 27710, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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NYU Langone Health
New York, New York, 10016, United States
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Other studies related to the condition(s) this trial covers.
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- Can engineered immune cells tame a debilitating autoimmune disease?