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SP Thoracic IDE Study | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

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

NCT05150210•Intuitive Surgical

View on ClinicalTrials.gov

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

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (6)

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

Key Dates

Start Date

July 20, 2022

Primary Completion Date

June 16, 2023

Completion Date

July 1, 2028

Last Updated

December 23, 2025

Enrollment

ACTUAL participants

Conditions

Primary Lung CancerBenign Lung DiseaseThymomaMyasthenia Gravis

Interventions

Robotic-Assisted Surgery

DEVICE

HEARTS Trial for Thoracic Cancers

NCT07132918

Non-Small Cell Lung Cancer (Stage III)Esophageal Cancer Stage I-III+3 more

View study

RECRUITINGPHASE2

Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma

NCT06838910

Thymic CarcinomaThymoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SP Thoracic IDE Study

Inclusion Criteria

Exclusion Criteria

HEARTS Trial for Thoracic Cancers

Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma

IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers

PT-112 in Subjects With Thymoma and Thymic Carcinoma

Robot-assisted vs VATS for Thymoma

Efficiency and Safety of Microwave Ablation Plus Immune Checkpoint Inhibitor for Patients With Multiple Primary Lung Cancer: A Open, Multi-center, Phase II Clinical Trial