Colorectal Adenoma and CarcinomaNCT07453706
The Application of Sentire Surgical System Plus Patient Side Single Arm in Robotic Colorectal Surgery
A study testing Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm in people with Colorectal Adenoma and Carcinoma, 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 years and older
- Conditions the study is for
- Colorectal Adenoma and Carcinoma
- What is being tested?
- Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Mar 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 years and older
- 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
- Body mass index <35 kg/m2
- Willingness to participate as demonstrated by giving informed consent
Who cannot join
- T4 tumor
- Recurrent tumor
- Extensive previous abdominal surgery precluding minimally invasive surgery
- Contraindication to general anesthesia
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- Untreated active infection
Show all 10Show fewer
- 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. Contact the study team or a site near you to ask about taking part.
China1 site
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Simon SM Ng, MD, +852-35051495, simonng@surgery.cuhk.edu.hk
Kaori Futaba, MD, +852-35051495, kfutaba@surgery.cuhk.edu.hk
About this study
Official title: The Application of Sentire Surgical System Plus Patient Side Single Arm in Robotic Colorectal Surgery: A Prospective 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 Surgical System C1000 had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal surgery. Recently, a new component of the system - the Patient Side Single Arm, is developed. It is an independent robotic arm designed for compatibility with the Sentire Surgical System, creating the hybrid surgical system known as the C1000 Ultra. The new component may enhance port placement flexibility, minimize arm collisions with the patient or operating table, and optimize docking for seamless integration into the operating room. The Patient Side Single Arm was proven by a preclinical study using cadaveric models to be safe and effective. The investigators would therefore like to conduct a prospective clinical study to evaluate the efficacy and safety of Sentire Surgical System Plus the Patient Side Single Arm in robotic colorectal surgery. The investigators believe that the results of this study will provide data to support its use for wide range of colorectal procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical applications for minimally invasive surgery with a cost-effective model.
- Conditions
- Colorectal Adenoma and Carcinoma
- Being tested
- Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm
- Medical subject headings
- Carcinoma
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 System Plus Patient Side Single ArmProcedure or surgery
Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm | Experimental | Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm Receives: Procedure: Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm |
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 or unplanned change in the treatment plan to conventional laparoscopic or 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 (8)
Operative time
Measured: Perioperative
Operative blood loss
Measured: Perioperative
Pain scores on visual analog scale
Pain scores on visual analog scale range from 0 which implies no pain at all, to 100 which implies the worst pain imaginable.
Measured: Up to 1 month
Analgesic requirement
Total doses of paracetamol and tramadol used postoperatively.
Measured: Up to 1 month
Length of hospital stay
Measured: Up to 1 month
Completeness of resection
Completeness of total mesorectal excision (TME) is classified as complete, nearly complete, or incomplete based on gross pathologic assessment. Complete TME is defined as intact mesorectum with only minor irregularities of a smooth mesorectal surface; no defect is deeper than 5 mm; no coning toward the distal margin; and smooth circumferential resection margin (CRM) on slicing. Nearly complete TME is defined as moderate bulk to the mesorectum; irregularity of the mesorectal surface; moderate coning of the specimen; and lack of visibility of the muscularis propria visible at any site, with the exception of the insertion of the levator muscles. Incomplete TME is defined as little bulk to mesorectum with defects down onto muscularis propria and/or very irregular CRM.
Measured: Up to 1 month
Resection margin positivity for malignancy
A circumferential resection margin <1mm is defined as positive; a distal resection margin <1 mm is defined as positive.
Measured: Up to 1 month
Number of lymph nodes harvested
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Adenoma and 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
- 12 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453706
- Sponsor's protocol ID
- CREC 2025.712
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2026
- Last updated
- 9 Mar 2026
- 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Sentire Surgical System Plus Patient Side Single Arm in Robotic Colorectal Surgery: A Prospective Study
- ClinicalTrials.gov ID
- NCT07453706
- Acronym / sponsor ID
- CREC 2025.712
- Conditions
- Colorectal Adenoma and Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Mar 2026 (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 Surgical System C1000 had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal surgery. Recently, a new component of the system - the Patient Side Single Arm, is developed. It is an independent robotic arm designed for compatibility with the Sentire Surgical System, creating the hybrid surgical system known as the C1000 Ultra. The new component may enhance port placement flexibility, minimize arm collisions with the patient or operating table, and optimize docking for seamless integration into the operating room. The Patient Side Single Arm was proven by a preclinical study using cadaveric models to be safe and effective. The investigators would therefore like to conduct a prospective clinical study to evaluate the efficacy and safety of Sentire Surgical System Plus the Patient Side Single Arm in robotic colorectal surgery. The investigators believe that the results of this study will provide data to support its use for wide range of colorectal procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical applications for minimally invasive surgery with a cost-effective model.
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 Plus Patient Side Single Arm | Experimental | Procedure: Robotic surgery using the Sentire Surgical System Plus Patient Side Single ArmRobotic surgery using the Sentire Surgical System Plus Patient Side Single Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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
- Body mass index <35 kg/m2
- Willingness to participate as demonstrated by giving informed consent
Key exclusion criteria (10 listed)
- T4 tumor
- Recurrent tumor
- Extensive previous abdominal surgery precluding minimally invasive surgery
- Contraindication to general anesthesia
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
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 System Plus Patient Side Single ArmRobotic surgery using the Sentire Surgical System Plus Patient Side Single Arm | Procedure or surgery | Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm |
Primary outcome
Conversion rate
Time frame: Up to 1 month
The definition of a conversion for this study is an emergent or unplanned change in the treatment plan to conventional laparoscopic or 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.
8 secondary outcomes
Operative time
Time frame: Perioperative
Operative blood loss
Time frame: Perioperative
Pain scores on 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
Completeness of resection
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
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 9 Mar 2026.
- 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.
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 Plus Patient Side Single Arm in people with Colorectal Adenoma and Carcinoma, 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 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: opening soon, as of the sponsor's last update on 9 Mar 2026. 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 9 Mar 2026.