Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery

NCT06926374 | Recruiting DMC

• 1 other identifier: CREC 2025.109-T
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colorectal Carcinoma; Rectal Prolapse; Prostate Cancer (Adenocarcinoma); Bladder Cancer; Kidney Cancer; Hiatal Hernia With Gastroesophageal Reflux Disease; GIST - Gastrointestinal Stromal Tumor; Esophageal Cancer; Gallstones; Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 1 month

Secondary Outcomes (10)

• Operative time

  Up to 1 month

• Operative blood loss

  Up to 1 month

• Pain scores on a visual analog scale

  Up to 1 month

• Analgesic requirement

  Up to 1 month

• Length of hospital stay

  Up to 1 month

Study Arms (1)

Robotic surgery using the Sentire Surgical System

EXPERIMENTAL

Robotic surgery using the Sentire Surgical System

Procedure: Robotic surgery using the Sentire Surgical System

Interventions

Robotic surgery using the Sentire Surgical System PROCEDURE

Robotic surgery using the Sentire Surgical System

Robotic surgery using the Sentire Surgical System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Robotic Colorectal Resection
• \- 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
• T4 tumor
• Recurrent tumor
• Extensive previous abdominal surgery precluding minimally invasive surgery
• Robotic Transanal Total Mesorectal Excision
• \- Mid/low rectal adenocarcinoma located \<12 cm from the anal verge
• T4 tumor or involvement of circumferential resection margin even after neoadjuvant therapy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Prolapse; Prostatic Neoplasms; Adenocarcinoma; Urinary Bladder Neoplasms; Kidney Neoplasms; Gastrointestinal Stromal Tumors; Esophageal Neoplasms; Gallstones; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Kidney Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Head and Neck Neoplasms; Esophageal Diseases; Cholelithiasis; Biliary Tract Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Stomach Diseases

Study Officials

• Simon SM Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon SM Ng, MD

CONTACT

+852-35051495; simonng@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wei Lun Professor of Surgery

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)