NCT05151835

Brief Summary

This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

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

November 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

August 24, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

November 5, 2021

Last Update Submit

November 4, 2023

Conditions

Robotic Surgery

Outcome Measures

Primary Outcomes (1)

  • Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System

    Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System is defined as the need to change to laparoscopic surgery during the procedure.

    30 days

Secondary Outcomes (6)

  • Rate of perioperative complications

    30 days

  • intraoperative time

    30 days

  • Blood Loss

    30 days

  • Pain scores on a visual analog scale

    30 days

  • Analgesic requirement

    30 days

  • +1 more secondary outcomes

Study Arms (1)

Robotic Surgery

EXPERIMENTAL

Prospective single arm study to investigate effect of a novel robotic surgical system on safety, efficacy and outcomes for performance of minimally invasive surgery across urology, upper and lower GI surgery.

Device: K2 Robotic Surgical System

Interventions

K2 Robotic Surgical SystemDEVICE

The K2 Robotic Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery in the thorax and abdomen. The K2 Robotic Surgical System consists of a Surgeon Console \[SGC\], a Patient Side Robot \[PSR\], and a Vision Cart \[VCT\], and is used with an endoscope, Surgical Instruments \[SGI\], and Accessories \[ACC\]. The surgeon views the three-dimensional endoscopic image on a High-Resolution Stereo Viewer (3D Viewer), which provides a view of the abdominal cavity and surgical instrumentation, along with icons and other user interface features.

Robotic Surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index \<35 kg/m2
  • Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases
  • Willingness to participate as demonstrated by giving informed consent

You may not qualify if:

  • Contraindication to general anesthesia
  • Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
  • Untreated active infection
  • Noncorrectable coagulopathy
  • Presence of another malignancy or distant metastasis
  • Emergency surgery
  • Vulnerable population (e.g. mentally disabled, pregnancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong

Hong Kong, Outside of US & Canada, 00000, China

RECRUITING

Study Officials

  • Simon SM Ng, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip WY Chiu, MD

CONTACT

+85291252907philipchiu@surgery.cuhk.edu.hk

Man Yee YUNG, RN

CONTACT

+85235052956myyung@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2021

First Posted

December 9, 2021

Study Start

August 24, 2022

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)