Clinical trial NCT05150210: SP Thoracic IDE Study
Official title: A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary and Lobectomy for Benign and Malignant Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Lung Cancer
Benign Lung Disease
Thymoma
Myasthenia Gravis
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2021-12-09
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Conversion
timeFrame: Intra-operative period
measure: Adverse Event Rate
timeFrame: Intra-operative through the 30 days follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Rice, MD
role: PRINCIPAL_INVESTIGATOR
References: