SP Thoracic IDE Study

Not Applicable

Active, not recruiting

• Conditions: Primary Lung Cancer; Thymoma; Myasthenia Gravis; Benign Lung Disease
• Interventions: Device: Robotic-Assisted Surgery

• Registration Number: NCT05150210
• Lead Sponsor: Intuitive Surgical

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.

Study Timeline

• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-09
• Study Start: 2022-07-20
• Primary Completion: 2023-06-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SP Surgical System	Robotic-Assisted Surgery	Pulmonary lobectomy and thymectomy procedures will be performed by da Vinci SP Surgical System.

Primary Outcome Measures

Name	Time	Method
Adverse Event Rate	Intra-operative through the 30 days follow-up period	Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
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

Trial Locations

Locations (6)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States