Clinical trial · Interventional
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
NCT05403190CI-TRIAL-00064153CGMH-SPEAR-PunknownN/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)
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
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| da Vinci SP system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study arm
- description
- Patients with prostate cancer
- interventionNames
- Device: da Vinci SP system
Primary outcomes (1)
- measure
- Success rate (%)
- timeFrame
- immediately after the surgery
- description
- Percentage of successful extraperitoneal approach radical prostatectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion.)
Secondary outcomes (19)
- measure
- Perioperative parameters-incision length (cm)
- timeFrame
- immediately after the surgery
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with biopsy-proved prostate cancer 2. Stage clinical T1-T2N0M0 3. Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies) 4. BMI ≦ 35 kg/m 5. Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function) 6. Age between 18 and 78 years old 7. Suitable for minimally invasive surgery 8. Patients willing and able to provide informed consent 9. Patients willing and able to comply with study protocol requirements and follow-up Exclusion Criteria: 1. Previous abdominal or pelvic major operation history 2. Previous radiation treatment to the pelvic area 3. Patients received transurethral resection of prostate in three months 4. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions * Severe heart disease (NYHA functional class III-IV) * Severe lung disease (GOLD Group C-D) 5. Anatomy unsuitable for endoscopic visualization or minimally invasive surgery 6. Hemodynamic or respiratory instability after anesthesia 7. Working space restriction (e.g. kyphosis or severe scoliosis) 8. Emergency surgery 9. Untreated active infection 10. vulnerable populations
References
Publications (1)
- DERIVEDLin PH, Wang HJ, Kan HC, Pang ST, Yu KJ, Wu CT. Comparable oncological and functional outcomes of robot-assisted radical prostatectomy with conventional anterior approach and Hood technique using DAVINCI SP system. Sci Rep. 2025 Nov 28;15(1):45652. doi: 10.1038/s41598-025-30245-5. PMID 41315721