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

Primary Purpose

Robotic Surgical Procedure, Thymoma, Myasthenia Gravis

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Da Vinci SP surgical platform

About this trial

This is an interventional treatment trial for Robotic Surgical Procedure focused on measuring single incision robotic minimal invasive surgery, robotic mediastinal tumor resection, da Vinci SP® surgical system

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

Age >20 and <75 years-old
Willing and able to provide informed consent
ASA≤ 3
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
Class I-IV Myasthenia gravis according to the Myasthenia Gravis Foundation of America Scientific Session (MGFA)

Exclusion criteria. Myasthenia gravis or thymoma patients with

Congestive heart failure (NHYA > II)
Arrhythmia required medication control
Subjects with a known bleeding or clotting disorder
Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation
Subjects under immunomodulatory within 30 days prior to the planned surgery
Previous ipsilateral thoracic surgery or sternotomy
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
Previous neoadjuvant medical and/or radiation therapy
Subject has a contraindication for general anesthesia or surgery
Uncontrolled myasthenia gravis symptoms at the time of scheduled surgery
Confirmed thymic carcinoma
Patients who are not suitable for performing endoscopic surgery.
Myasthenia gravis patients with positive serum MuSK antibody. -

Sites / Locations

Chang Gung Memeorial Hospital, Linkou Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Patients with qualified criteria will be enrolled in this study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05455840

First Posted

May 16, 2022

Last Updated

January 18, 2023

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05455840

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 3, 2022 (Actual)

Primary Completion Date

July 24, 2023 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Endpoints (Outcome measures)： 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 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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Robotic Surgical Procedure, Thymoma, Myasthenia Gravis

Keywords

single incision robotic minimal invasive surgery, robotic mediastinal tumor resection, da Vinci SP® surgical system

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

thymothmectomy or extended thymectomy through Da Vinci SP platform

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Patients with qualified criteria will be enrolled in this study

Intervention Type

Device

Intervention Name(s)

Da Vinci SP surgical platform

Intervention Description

using Da Vinci SP platform in thymothymectomy or extended thymectomy

Primary Outcome Measure Information:

Title

Incidence of conversion rate

Description

Time Frame

During Surgery

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events

Description

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Age >20 and <75 years-old Willing and able to provide informed consent ASA≤ 3 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 Class I-IV Myasthenia gravis according to the Myasthenia Gravis Foundation of America Scientific Session (MGFA) Exclusion criteria. Myasthenia gravis or thymoma patients with Congestive heart failure (NHYA > II) Arrhythmia required medication control Subjects with a known bleeding or clotting disorder Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation Subjects under immunomodulatory within 30 days prior to the planned surgery Previous ipsilateral thoracic surgery or sternotomy 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 Previous neoadjuvant medical and/or radiation therapy Subject has a contraindication for general anesthesia or surgery Uncontrolled myasthenia gravis symptoms at the time of scheduled surgery Confirmed thymic carcinoma Patients who are not suitable for performing endoscopic surgery. Myasthenia gravis patients with positive serum MuSK antibody. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yin Kai Chao, MD,PHD

Phone

+886975368205

chaoyk@cgmh.org.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Ching Feng Wu, MD

Phone

+886919327827

maple.bt88@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yin Kai Chao, MD,PHD

Organizational Affiliation

CHENG GUNG MEMORIAL HOSPITAL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chang Gung Memeorial Hospital, Linkou Medical Center

City

Taoyuan

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chao Yin-Kai, MD,PHD

Phone

+886975368205

chaoyk@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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