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Urologic NeoplasmsNCT05025930

Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).

A study of Urologic Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Robot-assisted surgery has been successfully adopted rapidly over the last decade. Robotic technology with tridimensional imaging can improve operating dexterity, visualization of difficult anatomic locations. This is a prospective study aims to evaluate the safety and effectiveness of the domestic surgical robot. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Urologic Neoplasms
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
1 Oct 2021to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any male or female age from 18 to 80
  • BMI 18-30kg/m2
  • Have urological surgery indications (cystectomy, prostatectomy, and nephrectomy)
  • Patients with physiologic conditions capable of receiving laparoscopic surgery
  • Be able to cooperate and complete the follow-up and related examinations
  • Volunteer to participate in this study and sign the informed consen

Who cannot join

  • The researchers assess patients with severe cardiovascular or circulatory disease and cannot tolerate the surgery
  • History of epilepsy or mental illness
  • Pregnant and lactation
  • Surgery history at the relevant surgical site, which is considered to influence surgical procedures
  • Severe allergic or addiction of drug and alcohol
  • Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastasis disease
Show all 10Show fewer
  • Inability to understand the trial or complete the follow-up
  • Participated in other therapeutic clinical trials within 90 days
  • Patients who had undergone major operation and major trauma within 28 days prior to enrollment, which the researchers considered to have an impact on the outcome of surgery
  • Patients deemed unsuitable to participate in this trial by researchers

Trial locations and contacts

1 site in 1 country.

Kaiwen Li, MD contact

+86-02034078960

likw6@mail.sysu.edu.cn

China1 site

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000): a Multi-center, Randomized, Single-blind, Parallel Controlled Clinical Tria

Robot-assisted surgery has been successfully adopted rapidly over the last decade. Robotic technology with tridimensional imaging can improve operating dexterity, visualization of difficult anatomic locations. This is a prospective study aims to evaluate the safety and effectiveness of the domestic surgical robot.

Read the detailed description

In this clinical trial, the subjects will be randomly divided into two groups, and the urological typical surgical procedures (prostatectomy, and partial or radical nephrectomy) will be performed with the endoscopic surgical instrument control system SP1000 and IS3000.And the non-inferiorly comparison will be made between the surgical results of two systems to verify the safety and effectiveness of the endoscopic surgical instrument control system (SP1000).

Being tested
endoscopic surgical instrument control system (SP1000: single-port laparoscopy), endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)
Medical subject headings
Urologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoscopic surgical instrument control system (SP1000: single-port laparoscopy)Device

    The system will be used in conjunction with other equipment during endoscopic surgery to accurately control endoscopic surgical instruments and perform delicate surgical procedures such as grasping, cutting, blunt separation, hemostasis, ligation and suture.

  • endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)Device

    The system will be used in conjunction with other equipment during endoscopic surgery to accurately control endoscopic surgical instruments and perform delicate surgical procedures such as grasping, cutting, blunt separation, hemostasis, ligation and suture.

Study groups in NCT05025930
Study groupRoleWhat they receive
endoscopic surgical instrument control system (SP1000: single- port laparoscopy)ExperimentalUrological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (SP1000)
Receives: Device: endoscopic surgical instrument control system (SP1000: single-port laparoscopy)
Comparator: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)Active comparatorUrological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (IS3000)
Receives: Device: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical success rate

    The surgical success rate was defined as the percentage of patients in the experimental group and the control group who were successfully operated with the systems

    Measured: 24 hours

  2. Incidence of serious adverse events during clinical trial

    Measured: 3 months

Secondary outcomes (10)

  1. Perioperative complication rate

    Perioperative complication will be graded using the Clavien-Dindo Complication Classification. The proportion and severity of perioperative complications will be analyzed

    Measured: 3 months

  2. Changes in serum creatinine

    Evaluating renal function by changes in serum creatinine after surgery for partial or radical nephrectomy

    Measured: 3 months

  3. Changes in prostate-specific antigen levels

    Changes in prostate-specific antigen levels will be measured after surgery for patients who undergone radical prostatectomy

    Measured: 3 months

  4. Tumor recurrence rate

    Measured: 3 months

  5. Machine installation time

    Time from sheeting to complete the installation of surgical instruments

    Measured: preoperative

  6. Operative time

    Measured: 12 hours

  7. Blood loss during the surgery

    Measured: 12 hours

  8. Margin positive rate

    Measured: 1 month

  9. Pain after surgery

    Visual analogue scale as a monitoring tool for postoperative pain

    Measured: 24 hours

  10. Surgeon Satisfaction

    NASA-TLX quantification table will be used to evaluate surgeon satisfaction after surgery

    Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2021
  2. Study start1 Oct 2021 (estimated)
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05025930
Sponsor's protocol ID
SysMU-Robot
Status last verified
Aug 2021
First submitted
9 Jul 2021
Last updated
2 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study of Urologic Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kaiwen Li, MD (+86-02034078960, likw6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical success rate (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05025930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.

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