Benign Lung Disease, Myasthenia Gravis, Primary Lung Cancer, Thymoma
Conditions
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.
Interventions
DEVICERobotic-Assisted Surgery
da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.
Sponsors
Intuitive Surgical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Conversion | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Rice, MD
M.D. Anderson Cancer Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SP Surgical System - Thymectomy Pulmonary thymectomy procedures performed by da Vinci SP Surgical System. | 13 |
| SP Surgical System - Lobectomy Pulmonary lobectomy procedures performed by da Vinci SP Surgical System. | 19 |
| Total | 32 |
Baseline characteristics
| Characteristic | Total | SP Surgical System - Lobectomy | SP Surgical System - Thymectomy |
|---|---|---|---|
| Age, Continuous Lobectomy | 66.4 years STANDARD_DEVIATION 8.06 | 66.4 years STANDARD_DEVIATION 8.06 | — |
| Age, Continuous Thymectomy | 54.5 years STANDARD_DEVIATION 15.86 | — | 54.5 years STANDARD_DEVIATION 15.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Female | 17 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 19 |
| other Total, other adverse events | 5 / 32 | 5 / 19 |
| serious Total, serious adverse events | 0 / 13 | 4 / 19 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SP Surgical System- Thymectomy Arm | Major Adverse Event Rate | 0 Participants |
| SP Surgical System - Lobectomy Arm | Major Adverse Event Rate | 3 Participants |
Primary
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
Population: 0 Conversions occured
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SP Surgical System- Thymectomy Arm | Rate of Conversion | 0 Participants |
| SP Surgical System - Lobectomy Arm | Rate of Conversion | 0 Participants |