Robotic SurgeryK2roboNCT05151835
Novel Robotic Surgical System for Minimally Invasive Surgery
A study testing K2 Robotic Surgical System in people with Robotic Surgery, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Robotic Surgery
- What is being tested?
- K2 Robotic Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2022to 30 Jan 2024
- 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
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
Hong Kong, Outside of US & Canada, 00000
Philip WY Chiu, MD, 85235053952, philipchiu@surgery.cuhk.edu.hk
Man Yee Yung, 85235052956, myyung@surgery.cuhk.edu.hk
About this study
Official title: A Novel Robotic Surgical System for Minimally Invasive Surgery: A Prospective, Single Center, Multi-speciality Study
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.
Read the detailed description
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 procedures will be standardized according to previously reported. The diseases for robotic surgical treatment will include prostate carcinoma, colorectal carcinoma, as well as esophageal hiatal diseases and gastric carcinoma. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.
- Conditions
- Robotic Surgery
- Being tested
- K2 Robotic Surgical System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: K2 Robotic Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (6)
Rate of perioperative complications
intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification
Measured: 30 days
intraoperative time
Intraoperative Time
Measured: 30 days
Blood Loss
Amount of blood loss in mls
Measured: 30 days
Pain scores on a visual analog scale
Pain score in visual analog scale scoring system (minimum 0 and maxium 10, higher score represents more pain)
Measured: 30 days
Analgesic requirement
Total dose of analgesic (Pethidine) used
Measured: 30 days
Length of Hospital Stay
Days after surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start24 Aug 2022
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Robotic SurgeryStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Wai Yan CHIU, Chinese University of Hong Kong
- Investigators
- Simon SM Ng, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151835
- Sponsor's protocol ID
- CREC 2021.472
- Acronym
- K2robo
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng CF, Yee CH, Chiu PKF, Tam MHM, Lai FPT. Evaluation of the safety and efficacy of the Sentire Surgical System (C1000) for robot-assisted radical prostatectomy. Hong Kong Med J. 2025 Jun;31(3):192-198. doi: 10.12809/hkmj2412169. Epub 2025 Jun 4.
PubMed 40461168
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Robotic Surgical System for Minimally Invasive Surgery: A Prospective, Single Center, Multi-speciality Study
- ClinicalTrials.gov ID
- NCT05151835
- Acronym / sponsor ID
- K2robo / CREC 2021.472
- Conditions
- Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 procedures will be standardized according to previously reported. The diseases for robotic surgical treatment will include prostate carcinoma, colorectal carcinoma, as well as esophageal hiatal diseases and gastric carcinoma. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Surgery | Experimental | Device: K2 Robotic Surgical SystemProspective 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K2 Robotic Surgical SystemThe 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. | Device | Robotic Surgery |
Primary outcome
Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System
Time frame: 30 days
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.
6 secondary outcomes
Rate of perioperative complications
Time frame: 30 days
intraoperative time
Time frame: 30 days
Blood Loss
Time frame: 30 days
Pain scores on a visual analog scale
Time frame: 30 days
Analgesic requirement
Time frame: 30 days
Length of Hospital Stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 40461168Ng CF, Yee CH, Chiu PKF, Tam MHM, Lai FPT. Evaluation of the safety and efficacy of the Sentire Surgical System (C1000) for robot-assisted radical prostatectomy. Hong Kong Med J. 2025 Jun;31(3):192-198. doi: 10.12809/hkmj2412169. Epub 2025 Jun 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon SM Ng, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K2 Robotic Surgical System in people with Robotic Surgery, run by Chinese University of Hong Kong 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 3 inclusion and 7 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 7 Nov 2023. 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 Philip WY Chiu, MD (+85291252907, philipchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System (time frame: 30 days). 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 NCT05151835, which also lists 1 linked publication.
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 7 Nov 2023.