Colorectal CarcinomaNCT06926374
Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
A study testing Robotic surgery using the Sentire Surgical System in people with Colorectal Carcinoma and Rectal Prolapse, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Robotic assisted surgery has been performed for more than two decades with good success and safety profile. However, there was only one dominating robotic surgical system available in the past which led to high cost for robotic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Carcinoma, Rectal Prolapse, Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Robotic surgery using the Sentire Surgical System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adenocarcinoma or large adenoma (not amenable to endoscopic removal) located at the colorectum (from the cecum to the anal verge) amenable to minimally invasive surgery
- Mid/low rectal adenocarcinoma located <12 cm from the anal verge
- Clinically diagnosed with previously untreated and uncomplicated rectal prolapse or enterocele
- Clinically diagnosed with nonmetastatic adenocarcinoma of prostate
- Clinically diagnosed with nonmetastatic kidney cancer
- Clinically diagnosed with nonmetastatic bladder cancer
Show all 11Show fewer
- Robotic Esophageal Hiatal Surgery and Fundoplication
- Clinically diagnosed with Hiatal Hernia and / or Gastroesophageal reflux disease amendable to fundoplication
- Clinical diagnosis of gastric tumor (Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)) amendable to minimally invasive radical gastrectomy
- Clinical diagnosis of carcinoma of esophagus amendable to minimally invasive esophagectomy
- Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy
Who cannot join
- T4 tumor
- Recurrent tumor
- Extensive previous abdominal surgery precluding minimally invasive surgery
- Robotic Transanal Total Mesorectal Excision
- T4 tumor or involvement of circumferential resection margin even after neoadjuvant therapy
- Tumor requiring multivisceral resection
Show all 25Show fewer
- Tumor requiring abdominoperineal resection; recurrent rectal tumor
- T1 tumor that can be treated by local excision
- Extensive previous abdominal surgery
- Robotic Rectopexy
- Extensive previous abdominal surgery precluding minimally invasive surgery
- Radical Prostatectomy
- Previous history of prostate surgery (e.g., transurethral resection of prostate)
- Total or Partial Nephrectomy
- Previous ipsilateral kidney surgery
- Complex kidney anatomy (e.g., horseshoe kidney, complex renal vascular anatomy)
- Radical Cystectomy
- Previous history of laparotomy precluding minimally invasive surgery
- Robotic Gastrectomy
- Previous history of laparotomy precluding minimally invasive surgery
- Robotic Esophagectomy
- Esophageal carcinoma after definitive chemoradiotherapy and indicated for salvage esophagectomy
- Robotic Cholecystectomy
- Acute cholecystitis
- Previous history of abdominal surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Simon SM Ng, MD, +852-35051495, simonng@surgery.cuhk.edu.hk
About this study
Robotic assisted surgery has been performed for more than two decades with good success and safety profile. However, there was only one dominating robotic surgical system available in the past which led to high cost for robotic surgery. Recently, a new robotic surgical system (Sentire Robotic Surgical System) was introduced by researchers of The Chinese University of Hong Kong (CUHK). This new robotic surgical system aims to achieve similar outcomes and standards of robotic surgery performed using the dominating system but with a significantly lower cost. The technologic innovation and development of this new robotic system is made by the Cornerstone Robotics Limited, which is based in Hong Kong. In a pilot clinical study conducted at Prince of Wales Hospital involving 55 patients, the Sentire Robotic Surgical System had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal, upper gastrointestinal, and urologic surgery. Researchers of CUHK would therefore like to conduct another prospective study to further evaluate the efficacy and safety of Sentire Surgical System C1000 in major gastrointestinal and urologic surgery with expanded indications. It is believed that the results of this study will provide data to support its use for wide range of procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical application for minimally invasive surgery with a cost-effective model.
Read the detailed description
As above.
- Conditions
- Colorectal Carcinoma, Rectal Prolapse, Prostate Cancer (Adenocarcinoma), Bladder Cancer, Kidney Cancer, Hiatal Hernia With Gastroesophageal Reflux Disease
- Being tested
- Robotic surgery using the Sentire Surgical System
- Medical subject headings
- Colorectal Neoplasms, Rectal Prolapse, Prostatic Neoplasms, Adenocarcinoma, Urinary Bladder Neoplasms, Kidney Neoplasms, Gastrointestinal Stromal Tumors, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgery using the Sentire Surgical SystemProcedure or surgery
Robotic surgery using the Sentire Surgical System
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery using the Sentire Surgical System | Experimental | Robotic surgery using the Sentire Surgical System Receives: Procedure: Robotic surgery using the Sentire Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
The definition of a conversion for this study is an emergent change in the treatment plan to conventional minimally invasive (laparoscopic/thoracoscopic) surgery (i.e., the use of more than one additional port), multiport robotic surgery, or to open surgery.
Measured: Up to 1 month
Perioperative complications
Perioperative complications including 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. Complications of Clavien-Dindo grade III (those requiring surgical, endoscopic, or radiologic intervention) or above are regarded as major complications.
Measured: Up to 1 month
Secondary outcomes (10)
Operative time
Measured: Up to 1 month
Operative blood loss
Measured: Up to 1 month
Pain scores on a visual analog scale
Measured: Up to 1 month
Analgesic requirement
Measured: Up to 1 month
Length of hospital stay
Measured: Up to 1 month
Resection margin positivity for malignancy
Measured: Up to 1 month
Number of lymph nodes harvested
Measured: Up to 1 month
Anal continence after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score)
The Cleveland Clinic Incontinence Score or Wexner's Score is the most common score used to determine the severity of incontinence before and after surgery for anal incontinence. The scoring system takes into account the type and frequency of incontinence, and the extent to which it alters the patient's life. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that may range from 0 to 20. Higher scores indicate higher levels of incontinence.
Measured: Up to 12 months
Male sexual function after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire)
IIEF-5 is an abridged five-item version of the 15-item International Index of Erectile Function (IIEF) which is used to diagnose the presence and severity of erectile dysfunction. This questionnaire consists of only five questions and each IIEF-5 item is scored on a five-point ordinal scale where lower values represent poorer sexual function. Thus, a response of 0 for a question is considered the least functional, whereas a response of 5 is considered the most functional. The possible scores for the IIEF-5 range from 1 to 25 (one question has scores of 1-5), and a score above 21 is considered as normal erectile function and at or below this cutoff, erectile dysfunction.
Measured: Up to 12 months
Urinary function after surgery, measured by the International Prostate Symptom Score (IPSS)
IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start25 Mar 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon S. M. Ng, Chinese University of Hong Kong
- Investigators
- Simon SM Ng, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926374
- Sponsor's protocol ID
- CREC 2025.109-T
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
- ClinicalTrials.gov ID
- NCT06926374
- Acronym / sponsor ID
- CREC 2025.109-T
- Conditions
- Colorectal Carcinoma, Rectal Prolapse, Prostate Cancer (Adenocarcinoma), Bladder Cancer, Kidney Cancer, Hiatal Hernia With Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Apr 2025 (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.
Robotic assisted surgery has been performed for more than two decades with good success and safety profile. However, there was only one dominating robotic surgical system available in the past which led to high cost for robotic surgery. Recently, a new robotic surgical system (Sentire Robotic Surgical System) was introduced by researchers of The Chinese University of Hong Kong (CUHK). This new robotic surgical system aims to achieve similar outcomes and standards of robotic surgery performed using the dominating system but with a significantly lower cost. The technologic innovation and development of this new robotic system is made by the Cornerstone Robotics Limited, which is based in Hong Kong. In a pilot clinical study conducted at Prince of Wales Hospital involving 55 patients, the Sentire Robotic Surgical System had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal, upper gastrointestinal, and urologic surgery. Researchers of CUHK would therefore like to conduct another prospective study to further evaluate the efficacy and safety of Sentire Surgical System C1000 in major gastrointestinal and urologic surgery with expanded indications. It is believed that the results of this study will provide data to support its use for wide range of procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical application for minimally invasive surgery with a cost-effective model.
Detailed description
As above.
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 using the Sentire Surgical System | Experimental | Procedure: Robotic surgery using the Sentire Surgical SystemRobotic surgery using the Sentire Surgical System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adenocarcinoma or large adenoma (not amenable to endoscopic removal) located at the colorectum (from the cecum to the anal verge) amenable to minimally invasive surgery
- Mid/low rectal adenocarcinoma located <12 cm from the anal verge
- Clinically diagnosed with previously untreated and uncomplicated rectal prolapse or enterocele
- Clinically diagnosed with nonmetastatic adenocarcinoma of prostate
- Clinically diagnosed with nonmetastatic kidney cancer
Key exclusion criteria (25 listed)
- T4 tumor
- Recurrent tumor
- Extensive previous abdominal surgery precluding minimally invasive surgery
- Robotic Transanal Total Mesorectal Excision
- T4 tumor or involvement of circumferential resection margin even after neoadjuvant therapy
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 |
|---|---|---|
| Robotic surgery using the Sentire Surgical SystemRobotic surgery using the Sentire Surgical System | Procedure or surgery | Robotic surgery using the Sentire Surgical System |
Primary outcome
Conversion rate
Time frame: Up to 1 month
The definition of a conversion for this study is an emergent change in the treatment plan to conventional minimally invasive (laparoscopic/thoracoscopic) surgery (i.e., the use of more than one additional port), multiport robotic surgery, or to open surgery.
Perioperative complications
Time frame: Up to 1 month
Perioperative complications including 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. Complications of Clavien-Dindo grade III (those requiring surgical, endoscopic, or radiologic intervention) or above are regarded as major complications.
10 secondary outcomes
Operative time
Time frame: Up to 1 month
Operative blood loss
Time frame: Up to 1 month
Pain scores on a visual analog scale
Time frame: Up to 1 month
Analgesic requirement
Time frame: Up to 1 month
Length of hospital stay
Time frame: Up to 1 month
Resection margin positivity for malignancy
Time frame: Up to 1 month
Number of lymph nodes harvested
Time frame: Up to 1 month
Anal continence after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score)
Time frame: Up to 12 months
Male sexual function after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire)
Time frame: Up to 12 months
Urinary function after surgery, measured by the International Prostate Symptom Score (IPSS)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- 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.
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 Robotic surgery using the Sentire Surgical System in people with Colorectal Carcinoma and Rectal Prolapse, 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 11 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 16 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon SM Ng, MD (+852-35051495, simonng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: Up to 1 month). 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?
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 16 Apr 2025.