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

Launched by CHINESE UNIVERSITY OF HONG KONG · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new robotic surgical system called the Sentire Robotic Surgical System, which is designed to help perform major surgeries for conditions like colorectal cancer, prostate cancer, and other gastrointestinal issues. The goal of the trial is to see if this new system can achieve the same successful outcomes as older, more expensive robotic systems, but at a lower cost. Researchers at The Chinese University of Hong Kong want to gather more data on its safety and effectiveness through this study, which will involve a wider range of surgeries and patients.

To participate in the trial, candidates must be between the ages of 18 and 75, have a body mass index (BMI) under 35, and be suitable for minimally invasive surgery for their specific condition. Participants will receive robotic-assisted surgery and will be monitored for their recovery and any complications. It's important to note that those with serious health issues, recent infections, or previous surgeries that would prevent minimally invasive techniques may not be eligible. This study hopes to benefit patients by making advanced surgical options more accessible and affordable.

Gender

ALL

Eligibility 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
• 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
• Exclusion Criteria:
• • T4 tumor
• • Recurrent tumor
• • Extensive previous abdominal surgery precluding minimally invasive surgery
• • Robotic Transanal Total Mesorectal Excision
• Inclusion Criteria:
• • - Mid/low rectal adenocarcinoma located \<12 cm from the anal verge
• Exclusion Criteria:
• • 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
• Inclusion Criteria:
• • Clinically diagnosed with previously untreated and uncomplicated rectal prolapse or enterocele
• Exclusion Criteria:
• • - Extensive previous abdominal surgery precluding minimally invasive surgery
• • Radical Prostatectomy
• Inclusion Criteria:
• • - Clinically diagnosed with nonmetastatic adenocarcinoma of prostate
• Exclusion Criteria:
• • - Previous history of prostate surgery (e.g., transurethral resection of prostate)
• • Total or Partial Nephrectomy
• Inclusion Criteria:
• • - Clinically diagnosed with nonmetastatic kidney cancer
• Exclusion Criteria:
• • Previous ipsilateral kidney surgery
• • Complex kidney anatomy (e.g., horseshoe kidney, complex renal vascular anatomy)
• • Radical Cystectomy
• Inclusion Criteria:
• • - Clinically diagnosed with nonmetastatic bladder cancer
• • Robotic Esophageal Hiatal Surgery and Fundoplication
• Inclusion Criteria:
• • - Clinically diagnosed with Hiatal Hernia and / or Gastroesophageal reflux disease amendable to fundoplication
• Exclusion Criteria:
• • - Previous history of laparotomy precluding minimally invasive surgery
• • Robotic Gastrectomy
• Inclusion Criteria:
• • - Clinical diagnosis of gastric tumor (Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)) amendable to minimally invasive radical gastrectomy
• Exclusion Criteria:
• • - Previous history of laparotomy precluding minimally invasive surgery
• • Robotic Esophagectomy
• Inclusion Criteria:
• • - Clinical diagnosis of carcinoma of esophagus amendable to minimally invasive esophagectomy
• Exclusion Criteria:
• • - Esophageal carcinoma after definitive chemoradiotherapy and indicated for salvage esophagectomy
• • Robotic Cholecystectomy
• Inclusion Criteria:
• • - Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy
• Exclusion Criteria:
• • Acute cholecystitis
• • Previous history of abdominal surgery