Taking people in ChinaNo phase

Tests a new robotic surgery system in gut and urinary tract operations

Tests a robotic surgical system during bowel, stomach and urinary tract operations in adults.

Key facts

Who runs it: Chinese University of Hong Kong
Where: Hong Kong, ChinaSee the site
Trial code: NCT06926374
Registry title: Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
Status: Recruiting
People taking part: 90 people, planned
Started: 25 Mar 2025
Expected to end: Apr 2027
Type of study: Interventional
Treatments tested: Robotic surgery using the Sentire Surgical System
Record updated: 16 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who need major stomach, bowel or urinary-tract surgery, or gallbladder or reflux surgery, done with the Sentire robotic system.

Age: 18 to 80 years
Sex: All sexes can join.
Disease stage: Colorectal, rectal, stomach, esophageal, prostate, kidney or bladder cancer, rectal prolapse, hiatal hernia or reflux, or gallstones that cause symptoms. Prostate, kidney and bladder cancer must not have spread.
Earlier treatment: For rectopexy, the rectal prolapse must be previously untreated. People with extensive earlier abdominal surgery, earlier prostate surgery or earlier surgery on the same kidney cannot join those procedures.

Main reasons for not taking part

Body mass index of 35 kg/m2 or more
Another cancer or cancer that has spread to distant organs
Emergency surgery, untreated active infection, or a bleeding disorder that cannot be corrected
Cannot have general anesthesia, or a severe illness that greatly shortens life or raises surgery risk
Vulnerable groups, for example mentally disabled people or pregnancy

The registry criteria, word for word

Show all 38 criteriaShow less

Who can take part

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

Who cannot take part

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
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
Previous history of laparotomy precluding minimally invasive surgery; Robotic Gastrectomy
Previous history of laparotomy precluding minimally invasive surgery; Robotic Esophagectomy
Previous history of abdominal surgery
T4 tumor
Recurrent tumor
T1 tumor that can be treated by local excision
Complex kidney anatomy (e.g., horseshoe kidney, complex renal vascular anatomy); Radical Cystectomy
Esophageal carcinoma after definitive chemoradiotherapy and indicated for salvage esophagectomy; Robotic Cholecystectomy
Acute cholecystitis

Other criteria

General Inclusion Criteria for All Procedures:
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; General Exclusion Criteria for All Procedures:
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 80 years old?

Where in China

Prince of Wales Hospital, The Chinese University of Hong KongHong Kong, ChinaContact: Simon SM Ng, MDTaking people

About the trial

What the trial wants to find out

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.