Status not kept up to date
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Mediastinal Disease
NCT05455840 · Chang Gung Memorial Hospital · Updated 31 Oct 2023
- What is being tested
- Da Vinci SP surgical platform
- For
- Robotic Surgical Procedure; Thymoma; Myasthenia Gravis
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 20 years to 75 years. About 15 people. The full rules are on the registry page.
- Where
- Taiwan
- When
- Starts or started 3 Aug 2022, ends 11 April 2024. Registered 13 July 2022.
- Results
- None posted yet.
In the researchers' words
Endpoints (Outcome measures)： 1. Primary endpoint: Incidence of conversion rate during surgery \- The primary performance endpoint will be assessed as the ability to successfully complete the planned mediastinal procedure with da Vinci SP System, with no conversion to open surgery, video-assisted thoracoscopic surgery (VATS), multi-port robotic surgery or approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach. Use of additional assistant port(s) is not considered a conversion 2. Secondary endpoints: Incidence of treatment related adverse events - The 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
Sites
- Chang Gung Memeorial Hospital, Linkou Medical CenterTaoyuan, Taiwan