Clinical trial · Interventional
Single Port Robotic Lung Anatomical Resection
Pilot Study of Single Port Robotic Surgery for Anatomical Lung Resection
NCT05535712CI-TRIAL-00070945unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Robotic Surgical Procedure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lung Anatomic Resection (Da Vinci SP) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Da Vinci SP intervnetion group
- description
- for patients who received Da Vinci SP robotic surgery
- interventionNames
- Device: Lung Anatomic Resection (Da Vinci SP)
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 anatomic resection procedure with the da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery. Usage of additional assistant port(s) is not considered a conversion.
Secondary outcomes (6)
- measure
- Incidence of Treatment Related Adverse Events
- timeFrame
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 is undergoing the following procedures 1. diagnosis with of clinical stage I lung cancer 2. The primary tumor should be less than ≤4cm diameter and ≥ 2 cm away from the origin of the associated lobar bronchus 5. Preoperative platelet count 150-400 (1000/ uL) Exclusion Criteria: 1. Congestive heart failure (NHYA \> II) 2. Subjects with a known bleeding or clotting disorder 3. Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation 4. Subjects under immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgery 5. Subjects with pulmonary hypertension 6. In need of extended resection (e.g. Chest wall, Carina, major vessel, bilobectomy) and reconstruction (e.g. Sleeve resection, bronchoplasty, angioplasty) 7. Previous ipsilateral thoracic surgery or sternotomy 8. 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 9. Previous neoadjuvant medical and/or radiation therapy 10. Subject has a contraindication for general anesthesia or surgery 11. Life expectancy \< 6 months 12. Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery 13. Subjects belong to vulnerable population (e.g., pregnancy or breastfeeding) 14. International normalized ratio, INR \>1.4 15. Activated Partial Thromboplastin Time , APTT \>35 -
References
Publications (1)
- DERIVEDCheng C, Tagkalos E, Ng CB, Hsu YC, Huang YY, Wu CF, Chao YK. Subcostal uniportal robotic anatomic lung resection: A pilot trial. JTCVS Tech. 2024 Apr 28;25:160-169. doi: 10.1016/j.xjtc.2024.01.024. eCollection 2024 Jun. PMID 38899114