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

NCT ID: NCT06926374

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2027-04-30

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.

Detailed Description

As above.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic surgery using the Sentire Surgical System

Robotic surgery using the Sentire Surgical System

Group Type: EXPERIMENTAL

Robotic surgery using the Sentire Surgical System

Intervention Type: PROCEDURE

Robotic surgery using the Sentire Surgical System

Interventions

Robotic surgery using the Sentire Surgical System

Robotic surgery using the Sentire Surgical System

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

Exclusion Criteria

• 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

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Simon S. M. Ng

Wei Lun Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon SM Ng, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Simon SM Ng, MD

Role: CONTACT

simonng@surgery.cuhk.edu.hk

+852-35051495

Facility Contacts

Simon SM Ng, MD

Role: primary

simonng@surgery.cuhk.edu.hk

+852-35051495

Other Identifiers

CREC 2025.109-T

Identifier Type: -

Identifier Source: org_study_id