Tokyo, Nov. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059896) titled 'A prospective observational study to evaluate the safety of robot-assisted gastrectomy using the da Vinci SP' on Nov. 26.
Study Type:
Observational
Primary Sponsor:
Institute - Osaka Keisatsu Hospital
Condition:
Condition - gastric cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - Efficacy and safety of robotic-assisted gastrectomy using the da Vinci SP for gastric cancer
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Gastric cancer patients who are eligible for robotic-assisted gastrectomy using a da Vinci SP based on preoperative examination.
2) Patients who are willing to follow the research protocol.
3) Patients have signed a consent form for participation in the study that has been approved by our institution's ethical review board. However, a proxy may sign only if the patient is unable to sign due to a physical disability.
Key exclusion criteria - 1) Women who may be pregnant or who are breastfeeding.
2) Patients with psychiatric illness or symptoms who are deemed to make it difficult to participate in the study.
3) Patients who are deemed to be inappropriate for endoscopic surgery.
4) Patients with serious medical conditions that the principal investigator or co-researcher deems inappropriate for participation in this study.
Target Size - 10
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 07 Month 06 Day
Date of IRB - 2005 Year 08 Month 07 Day
Anticipated trial start date - 2025 Year 08 Month 08 Day
Last follow-up date - 2028 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068500
Disclaimer: Curated by HT Syndication.