SP Thoracic IDE Study

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05150210
• Other study ID #: SP Thoracic IDE
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: July 2028

Study information

• Verified date: June 2024
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: July 2028
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Lung Disease
• Lung Diseases
• Myasthenia Gravis
• Primary Lung Cancer
• Thymoma

Intervention

Device:
• Robotic-Assisted Surgery
da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Duke University Hospital	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
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

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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