NCT05403190

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

February 22, 2023

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

May 18, 2022

Last Update Submit

February 21, 2023

Conditions

Prostate Cancer

Keywords

prostate cancerradical prostatectomyda Vinci SP systemextraperitoneal approach

Outcome Measures

Primary Outcomes (1)

  • Success rate (%)

    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.)

    immediately after the surgery

Secondary Outcomes (19)

  • Perioperative parameters-incision length (cm)

    immediately after the surgery

  • Perioperative parameters-console time (minutes)

    immediately after the surgery

  • Perioperative parameters-blood loss (ml)

    immediately after the surgery

  • Perioperative parameters-blood transfusion type

    immediately after the surgery

  • Perioperative parameters-blood transfusion unit

    immediately after the surgery

  • +14 more secondary outcomes

Study Arms (1)

Study arm

EXPERIMENTAL

Patients with prostate cancer

Device: da Vinci SP system

Interventions

da Vinci SP systemDEVICE

using da Vinci SP system to perform extraperitoneal approach radical prostatectomy

Study arm

Eligibility Criteria

Age18 Years - 78 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with biopsy-proved prostate cancer
  • Stage clinical T1-T2N0M0
  • Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies)
  • BMI ≦ 35 kg/m
  • Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function)
  • Age between 18 and 78 years old
  • Suitable for minimally invasive surgery
  • Patients willing and able to provide informed consent
  • Patients willing and able to comply with study protocol requirements and follow-up

You may not qualify if:

  • Previous abdominal or pelvic major operation history
  • Previous radiation treatment to the pelvic area
  • Patients received transurethral resection of prostate in three months
  • 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)
  • Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
  • Hemodynamic or respiratory instability after anesthesia
  • Working space restriction (e.g. kyphosis or severe scoliosis)
  • Emergency surgery
  • Untreated active infection
  • vulnerable populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

RECRUITING

Related Publications (1)

  • Lin 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: 41315721DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Chun-Te Wu, Professor, MD, PhD

    Chang Gung Memorial Hospital at Keelung

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Po-Hung Lin, MD

CONTACT

+886975366240m7587@cgmh.org.tw

Hung-Jen Wang, MD

CONTACT

+886975356239

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

June 3, 2022

Study Start

August 1, 2022

Primary Completion

July 31, 2023

Study Completion

November 30, 2023

Last Updated

February 22, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)