The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy (CGMH-SPEAR-P)

February 21, 2023 updated by: Chang Gung Memorial Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Hung-Jen Wang, MD
  • Phone Number: +886975356239

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study arm
Patients with prostate cancer
Device: da Vinci SP system
using da Vinci SP system to perform extraperitoneal approach radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success rate (%)
Time Frame: immediately after the surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perioperative parameters-incision length (cm)
Time Frame: immediately after the surgery
incision length
immediately after the surgery
Perioperative parameters-console time (minutes)
Time Frame: immediately after the surgery
console time
immediately after the surgery
Perioperative parameters-blood loss (ml)
Time Frame: immediately after the surgery
blood loss
immediately after the surgery
Perioperative parameters-blood transfusion type
Time Frame: immediately after the surgery
blood transfusion type
immediately after the surgery
Perioperative parameters-blood transfusion unit
Time Frame: immediately after the surgery
blood transfusion unit
immediately after the surgery
Perioperative parameters-intra-operative complications (SATAVA system)
Time Frame: immediately after the surgery
intra-operative complications accessed with SATAVA system, Grade 1 to 3, higher grade indicates serious complications
immediately after the surgery
Perioperative parameters-oxidative stress
Time Frame: immediately after the surgery
oxidative stress measured by the arterial malondialdehyde (MDA) level (micromole/L)
immediately after the surgery
Postoperative parameters-length of hospital stay (days)
Time Frame: immediately after discharge (assessed up to 10 days)
length of hospital stay
immediately after discharge (assessed up to 10 days)
Postoperative parameters-pain scale (VAS score)
Time Frame: Every day during admission after the surgery (up to 7 days)
pain scale accessed with visual analog scale (VAS) score, 1-10, higher score indicates more pain
Every day during admission after the surgery (up to 7 days)
Postoperative parameters-analgesic type
Time Frame: Every day during admission after the surgery (up to 7 days)
analgesic type
Every day during admission after the surgery (up to 7 days)
Postoperative parameters-analgesic dose
Time Frame: Every day during admission after the surgery (up to 7 days)
analgesic dose
Every day during admission after the surgery (up to 7 days)
Postoperative parameters-postoperative complications (CLAVIEN-DINDO system)
Time Frame: During admission after the surgery (up to 10 days)
postoperative complications accessed with CLAVIEN-DINDO system, Grade I to V, higher grade indicates severe complications
During admission after the surgery (up to 10 days)
Postoperative parameters-readmission and reoperation
Time Frame: If happens, on the day of re-admission or reoperations (up to 30 days)
Thirty-day readmission and reoperations in relation to the index procedure
If happens, on the day of re-admission or reoperations (up to 30 days)
Functional outcomes-continence status
Time Frame: Post-operation 1/3/6/12 months
Continence status after Foley catheter removed. Pad-free or one safe pad used are defined as continence intact. More than one pad used is defined as post-operative incontinence.
Post-operation 1/3/6/12 months
Functional outcomes-continence (pad amount)
Time Frame: Post-operation 1/3/6/12 months
pads used per day (for patients with incontinence)
Post-operation 1/3/6/12 months
Functional outcomes-continence (leak amount in gram)
Time Frame: Post-operation 1/3/6/12 months
24hr total weight of pads (for patients with incontinence)
Post-operation 1/3/6/12 months
Functional outcomes-sexual function change (IIEF-5)
Time Frame: Baseline, Post-operation 1/3/6/12 months
sexual function at baseline and 1/3/6/12 months with International Index of Erectile Function (IIEF-5), 0-25, higher score indicates better sexual function.
Baseline, Post-operation 1/3/6/12 months
Oncologic outcomes-margin status (positive or negative)
Time Frame: when the pathology report is available (up to day 10)
surgical margin status
when the pathology report is available (up to day 10)
Oncologic outcomes-biochemical recurrence
Time Frame: Post-operation 1/3/6/12 months
biochemical recurrence (PSA level ng/ml)
Post-operation 1/3/6/12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Intuitive Surgical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chun-Te Wu, Professor, MD, PhD, Chang Gung Memorial Hospital at Keelung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202101419A0C601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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