UnknownNot Applicable

Single Port Robotic Lung Anatomical Resection

Taiwan35 participantsStarted 2022-10-07

Plain-language summary

This is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform

Age range20 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age \>20 and \<75 years-old
✓. Willing and able to provide informed consent
✓. ASA≤ 3
✓. The subject is undergoing the following procedures
✓. diagnosis with of clinical stage I lung cancer
✓. The primary tumor should be less than ≤4cm diameter and ≥ 2 cm away from the origin of the associated lobar bronchus
✓. Preoperative platelet count 150-400 (1000/ uL)

✕. Congestive heart failure (NHYA \> II)
✕. 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 or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgery
✕. Subjects with pulmonary hypertension
✕. In need of extended resection (e.g. Chest wall, Carina, major vessel, bilobectomy) and reconstruction (e.g. Sleeve resection, bronchoplasty, angioplasty)
✕. 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

Incidence of conversion rate

Timeframe: During Surgery

NCT IDNCT05535712

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-05

Who can participate

Age range20 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age \>20 and \<75 years-old
✓. Willing and able to provide informed consent
✓. ASA≤ 3
✓. The subject is undergoing the following procedures
✓. diagnosis with of clinical stage I lung cancer
✓. The primary tumor should be less than ≤4cm diameter and ≥ 2 cm away from the origin of the associated lobar bronchus
✓. Preoperative platelet count 150-400 (1000/ uL)

✕. Congestive heart failure (NHYA \> II)
✕. 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 or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgery
✕. Subjects with pulmonary hypertension
✕. In need of extended resection (e.g. Chest wall, Carina, major vessel, bilobectomy) and reconstruction (e.g. Sleeve resection, bronchoplasty, angioplasty)
✕. 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