NCT05403190

The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy

The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy-a Single Arm Pivotal Trial Initiated by Chang Gung Memorial Hospital, Taiwan

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the performance and safety of da Vinci Single Port (SP) system on the surgery for extraperitoneal approach radical prostatectomy

Detailed description

Enrolled subjects would receive extraperitoneal approach radical prostatectomy using da Vinci SP system and be assessed at baseline (preoperatively), during hospitalization, and postoperatively (at 1 month +/-4 days, 3 month +/- 7 days, 6 months +/- 10 days, 12month +/-14 days). The preoperative assessment includes any diagnostic tests to confirm the subjects' cancer status and eligibility for the intervention under consideration such as transrectal or transperineal biopsy, image studies for staging including MRI/CT and bone scan, and cardiopulmonary tests to evaluate risks for anesthesia. The hospitalization assessment includes the collection of perioperative and postoperative details, conversions, and complications. The postoperative assessment includes regular follow up studies to evaluate cancer status and functional outcome (For sexual function, the International Index of Erectile Function (IIEF-5) would be recorded before and after the surgery. For continence, the number of pads per day and 24hr total weight of pads would be recorded. No pad used or one safe pad per day with net wet ≤ 50gm would be considered as continent. International Prostate Symptom Score (IPSS) wound be recorded before and after the surgery to access voiding function).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	da Vinci SP system	using da Vinci SP system to perform extraperitoneal approach radical prostatectomy

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-07-31
• Completion: 2023-11-30
• First posted: 2022-06-03
• Last updated: 2023-02-22

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study