SP Thoracic IDE Study

NCT ID: NCT05150210

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2028-07-31

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.

Conditions

Primary Lung Cancer; Benign Lung Disease; Thymoma; Myasthenia Gravis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SP Surgical System- Lobectomy procedures

Pulmonary lobectomy performed by da Vinci SP Surgical System.

Group Type: EXPERIMENTAL

Robotic-Assisted Surgery

Intervention Type: DEVICE

da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.

SP Surgical System - Thymectomy

Thymectomy procedures performed by the da Vinci SP Surgical System

Group Type: EXPERIMENTAL

Robotic-Assisted Surgery

Intervention Type: DEVICE

da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.

Interventions

Robotic-Assisted Surgery

da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.

Intervention Type: DEVICE

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

• Clinical stage I or II primary lung cancer or other suspected lung malignancy; or benign lung disease requiring resection; primary tumor ≤ 5cm diameter

• 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

• 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

• Uncontrolled myasthenia gravis symptoms at the time of scheduled surgery
• Tumor requiring resection of local structures (except pericardium)
• Confirmed thymic carcinoma

• Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intuitive Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Rice, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Hospital

Durham, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SP Thoracic IDE

Identifier Type: -

Identifier Source: org_study_id