Spots Global Cancer Trial Database for SP Thoracic IDE Study
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Trial Identification
Brief Title: SP Thoracic IDE Study
Official Title: A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary and Lobectomy for Benign and Malignant Disease
Study ID: NCT05150210
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Contact Details
Name: David Rice, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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