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Not yet recruiting NCT07453706

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

No phase Interventional Colorectal Adenoma and Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm.
Who it may be relevant to
Registry conditions: Colorectal Adenoma and Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Application of Sentire Surgical System Plus Patient Side Single Arm in Robotic Colorectal Surgery: A Prospective Study

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Conversion rate [Time frame: Up to 1 month]
  • Perioperative complications [Time frame: Up to 1 month]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Prince of Wales Hospital, The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07453706 · CREC 2025.712

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗