Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06926374

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

Led by Chinese University of Hong Kong · Updated on 2025-04-16

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Robotic-assisted surgery has been used successfully for over 20 years, mainly relying on one major system that results in high costs. Researchers from The Chinese University of Hong Kong (CUHK) have developed a new robotic surgical system called the Sentire Robotic Surgical System, designed to offer similar surgical outcomes at a significantly lower cost. An initial pilot study with 55 patients showed promising success and safety in colorectal, upper gastrointestinal, and urologic surgeries, leading to this further study to evaluate its use in major gastrointestinal and urologic surgeries with expanded indications. This study involves robotic surgery using the Sentire Surgical System for various minimally invasive procedures treating conditions like colorectal carcinoma, prostate cancer, bladder and kidney cancers, gastric and esophageal tumors, and others. The system aims to reduce trauma and costs compared to existing robotic platforms. The research will assess the surgical outcomes and safety profile of this technology in these procedures. Participants will undergo robotic surgeries with the Sentire system and be monitored for up to 12 months. Researchers will evaluate conversion rates to open surgery, perioperative complications, operative time, blood loss, pain levels, analgesic use, hospital stay length, surgical margin status, lymph node removal, and post-surgery functions including anal continence, male sexual function, and urinary function. These assessments will help determine the system's effectiveness and safety during and after surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 80 years
  • Body mass index less than 35 kg/m2
  • Suitable for listed minimally invasive surgical procedures for treatment of respective diseases
  • Willing to participate and able to provide informed consent
  • Diagnosed with conditions such as colorectal adenocarcinoma or large adenoma amenable to surgery, mid/low rectal adenocarcinoma, untreated uncomplicated rectal prolapse or enterocele, nonmetastatic adenocarcinoma of prostate, nonmetastatic kidney cancer, nonmetastatic bladder cancer, hiatal hernia or gastroesophageal reflux disease amendable to fundoplication, gastric tumors including adenocarcinoma or GIST, esophageal carcinoma amendable to minimally invasive surgery, or symptomatic gallbladder stones indicated for laparoscopic cholecystectomy
Not Eligible

You will not qualify if you...

  • Contraindication to general anesthesia
  • Severe concomitant illness reducing life expectancy or increasing surgical risk
  • Untreated active infection
  • Noncorrectable coagulopathy
  • Presence of another malignancy or distant metastasis
  • Emergency surgery
  • Vulnerable populations including mentally disabled or pregnancy
  • T4 tumors or recurrent tumors for colorectal and rectal surgeries
  • Extensive previous abdominal surgery preventing minimally invasive surgery
  • Tumors requiring multivisceral or abdominoperineal resection or salvage esophagectomy
  • Previous prostate surgery for radical prostatectomy candidates
  • Previous ipsilateral kidney surgery or complex kidney anatomy for nephrectomy
  • Previous laparotomy precluding minimally invasive surgery for esophageal, gastric, or hiatal surgeries
  • Acute cholecystitis or previous abdominal surgery for cholecystectomy candidates
  • Recurrent rectal tumor or tumors treatable by local excision for rectal surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 1 month

Participants undergo robotic surgery using the Sentire Surgical System followed by immediate post-operative care.

1 surgery visit and multiple post-operative visits during hospital stay

Post-operative Follow-up

Duration - Up to 12 months

Participants are followed to assess recovery, continence, sexual and urinary function after surgery.

Periodic follow-up visits up to 12 months

Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, China

Actively Recruiting

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Research Team

S

Simon SM Ng, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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