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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindication to general anesthesia

Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention

Untreated active infection

Noncorrectable coagulopathy

Trial design

Design model

Single group

Treatments tested in this trial

  • Robotic surgery using the Sentire Surgical System

    Procedure/Surgery

    Robotic surgery using the Sentire Surgical System

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Robotic surgery using the Sentire Surgical SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 1 month
2

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.

Time frame
Up to 1 month

Secondary outcomes

1

Operative time

Time frame
Up to 1 month
2

Operative blood loss

Time frame
Up to 1 month
3

Pain scores on a visual analog scale

Time frame
Up to 1 month
4

Analgesic requirement

Time frame
Up to 1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.