The Application of Sentire Surgical System Plus Patient Side Single Arm in Robotic Colorectal Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Adenoma and Carcinoma
• Intervention / Treatment: Procedure: Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon SM Ng, MD; Phone Number: +852-35051495; Email: simonng@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Kaori Futaba, MD; Phone Number: +852-35051495; Email: kfutaba@surgery.cuhk.edu.hk

Study Locations

• China
  • Hong Kong, China
    • Prince of Wales Hospital, The Chinese University of Hong Kong
    • Contact: Simon SM Ng, MD; Phone Number: +852-35051495; Email: simonng@surgery.cuhk.edu.hk
    • Contact: Kaori Futaba, MD; Phone Number: +852-35051495; Email: kfutaba@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Noncorrectable coagulopathy
• Presence of another malignancy or distant metastasis
• Emergency surgery
• Vulnerable population (e.g., mentally disabled, pregnancy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm	Procedure: Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm; Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 month
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.	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		Up to 1 month
Number of lymph nodes harvested		Up to 1 month
Operative time		Perioperative
Operative blood loss		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.	Up to 1 month
Analgesic requirement	Total doses of paracetamol and tramadol used postoperatively.	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.	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.	Up to 1 month

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: CREC 2025.712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No