Back to resultsSP Thoracic IDE Study
Primary Purpose
Primary Lung Cancer, Benign Lung Disease, Thymoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic-Assisted Surgery
Sponsored by
About this trial
This is an interventional other trial for Primary Lung Cancer
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
Sites / Locations
- Cedars-Sinai Medical Center
- Brigham and Women's Hospital
- NYU Langone Health
- Memorial Sloan Kettering Cancer Center
- Duke University Hospital
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SP Surgical System
Arm Description
Pulmonary lobectomy and thymectomy procedures will be performed by da Vinci SP Surgical System.
Outcomes
Primary Outcome Measures
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
Adverse Event Rate
Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05150210
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
July 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuitive Surgical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Lung Cancer, Benign Lung Disease, Thymoma, Myasthenia Gravis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SP Surgical System
Arm Type
Experimental
Arm Description
Pulmonary lobectomy and thymectomy procedures will be performed by da Vinci SP Surgical System.
Intervention Type
Device
Intervention Name(s)
Robotic-Assisted Surgery
Intervention Description
da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.
Primary Outcome Measure Information:
Title
Rate of Conversion
Description
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
Title
Adverse Event Rate
Description
Safety defined as the incidence of all 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rice, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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SP Thoracic IDE Study
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