A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Mediastinal Disease

Myasthenia Gravis Clinical Trial

Official title:

A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Mediastinal Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05455840
• Other study ID #: 202101422A0
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 3, 2022
• Est. completion date: April 11, 2024

Study information

• Verified date: October 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

During the past several years, minimally invasive thoracic surgery has evolved from thoracoscopic approaches using 3 -4 ports to a single incision video-assisted thoracoscopic surgery (VATS) techniques. Recently, the experience acquired with the uniportal VATS technique through the intercostal space has allowed the development of a uniportal VATS subxiphoid or subcostal approach for anterior mediastinal tumor resections. The advantage of using a subxiphoid or subcostal entry is to reduce pain by avoiding possible trauma of intercostal nerves caused by thoracic incisions. However, the longer distance from the subxiphoid or subcostal incision to the anterior mediastinal area makes this approach more difficult to perform extended thymothymectomy. During this same period of evolution into uniportal VATS surgery, robotic thoracic surgery has gained popularity as an alternative to traditional VATS. The advantages of robotics are the ability to perform surgery more precisely with articulated or wristed instruments, motion scaling, and tremor filtration, as well as improved visualization thanks to 3D high-definition video. However, currently 4 -5 incisions are still necessary to perform anatomic robotic resections.Recently, there has been a convergence of these two trends-uniportal surgery and robotic-assisted surgery-and has resulted in a single port robotic system, the da Vinci SP by Intuitive Surgical Cooperation. For this new platform, investigators plan to practice in extended thymothymectomy

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion criteria

1. Age >20 and <75 years-old

2. Willing and able to provide informed consent

3. ASA= 3

4. The subject fulfills one or both of the following criteria:

• Diagnosis of myasthenia gravis

• Masaoka stage I or II thymoma; thymic mass = 5 cm diameter

5. Class I-IV Myasthenia gravis according to the Myasthenia Gravis Foundation of America Scientific Session (MGFA)

Exclusion criteria. Myasthenia gravis or thymoma patients with

1. Congestive heart failure (NHYA > II)

2. Arrhythmia required medication control

3. Subjects with a known bleeding or clotting disorder

4. Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation

5. Subjects under immunomodulatory within 30 days prior to the planned surgery

6. Previous ipsilateral thoracic surgery or sternotomy

7. Uncontrolled 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

8. Previous neoadjuvant medical and/or radiation therapy

9. Subject has a contraindication for general anesthesia or surgery

10. Uncontrolled myasthenia gravis symptoms at the time of scheduled surgery

11. Confirmed thymic carcinoma

12. Patients who are not suitable for performing endoscopic surgery.

13. Myasthenia gravis patients with positive serum MuSK antibody. -

Related Conditions & MeSH terms

• Mediastinal Diseases
• Myasthenia Gravis
• Thymoma

Intervention

Device:
• Da Vinci SP surgical platform
using Da Vinci SP platform in thymothymectomy or extended thymectomy

Locations

Country	Name	City	State
Taiwan	Chang Gung Memeorial Hospital, Linkou Medical Center	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of conversion rate	The primary performance endpoint will be assessed as the ability to successfully complete the planned procedure with da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery.	During Surgery
Secondary	Incidence of Treatment-Emergent 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. Rceord the Incidence of Treatment-Emergent Adverse Events in our recording form	One year