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

NCT05455840 | Unknown DMC

• 1 other identifier: 202101422A0
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Endpoints (Outcome measures)：

1. 1.Primary endpoint: Incidence of conversion rate during surgery
2. 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

Conditions

Robotic Surgical Procedure; Thymoma; Myasthenia Gravis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  One year

Study Arms (1)

Intervention

EXPERIMENTAL

Patients with qualified criteria will be enrolled in this study

Device: Da Vinci SP surgical platform

Interventions

Da Vinci SP surgical platform DEVICE

using Da Vinci SP platform in thymothymectomy or extended thymectomy

Intervention

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memeorial Hospital, Linkou Medical Center

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Thymoma; Myasthenia Gravis

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yin Kai Chao, MD,PHD

  CHENG GUNG MEMORIAL HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: thymothmectomy or extended thymectomy through Da Vinci SP platform

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: July 13, 2022
• Study Start: August 3, 2022
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)