Clinical trial · Interventional
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Mediastinal Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
| Robotic Surgical Procedure | — | UNRESOLVED | — |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Da Vinci SP surgical platform | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Patients with qualified criteria will be enrolled in this study
- interventionNames
- Device: Da Vinci SP surgical platform
Primary outcomes (1)
- measure
- Incidence of conversion rate
- timeFrame
- During Surgery
- description
- 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 outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- One year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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. -
References
Publications (1)
- DERIVEDCheng C, Wen YW, Chien MS, Chao YK. Chronic Neuralgia After Single-Port Versus Multiport Trans-Subxiphoid Robotic Mediastinal Surgery: A Prospective Single-Arm Pilot Study With Historical Controls. Int J Med Robot. 2026 Apr;22(2):e70158. doi: 10.1002/rcs.70158. PMID 41923497