SP Thoracic IDE Study

A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary and Lobectomy for Benign and Malignant Disease

To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.

Study Overview

• Status: Active, not recruiting
• Conditions: Thymoma; Myasthenia Gravis; Primary Lung Cancer; Benign Lung Disease
• Intervention / Treatment: Device: Robotic-Assisted Surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ling Lin; Email: ling.lin@intusurg.com
• Study Contact Backup: Name: Jennifer Mueller; Phone Number: 510-552-9880; Email: jennifer.mueller@intusurg.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10016
      • NYU Langone Health
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SP Surgical System; Pulmonary lobectomy and thymectomy procedures will be performed by 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intra-operative period
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.	Intra-operative through the 30 days follow-up period

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: David Rice, MD, M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Actual): June 16, 2023
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Neoplasms by Site; Thoracic Neoplasms; Neuromuscular Diseases; Neurodegenerative Diseases; Nervous System Neoplasms; Neoplasms, Complex and Mixed; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Thymus Neoplasms; Lung Diseases; Thymoma; Myasthenia Gravis
• Other Study ID Numbers: SP Thoracic IDE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes