Clinical Trial Protocol for Evaluating the Efficacy and Safety of Thoracoabdominal Endoscopic Surgery System in Remote Laparoscopic Surgery for Urology, General Surgery, Gynecology and Thoracic Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCornerstone Robotics

About this trial

Evaluation of the Efficacy and Safety of the Thoracoabdominal Endoscopic Surgery System Produced by Shenzhen Cornerstone Robotics Technology Co., Ltd. in Remote Laparoscopic Surgeries for Urology, General Surgery, Gynecology and Thoracic Surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 and ≤ 80 years;

Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.).

Subjects voluntarily participate in the clinical trial, and subjects or their guardians give informed consent and sign the informed consent form.

Willing to cooperate with and complete trial follow-ups and relevant examinations.

Disqualifiers

Need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.);

With other malignancies or a previous history of other malignancies.

Preoperative imaging suggests that the tumour has distant metastases.

The patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment.

Trial population

Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.).

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Robot-assisted surgery

    Device

    Surgery with the Cornerstone Surgical Robot.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Surgical non-referral rate

Surgical untransferred is defined as not converted from an experimental medical device assisted method to another surgical device control system assisted, laparoscopic surgery or open surgery.

Time frame
during the surgery

Secondary outcomes

1

The surgeon's operating time

Operative time(minutes)

Time frame
during the surgery
2

Intraoperative blood loss

Estimated blood loss(milliliters,ml)

Time frame
during the surgery
3

Length of stay

The postoperative day when patients complied with the predefined discharge criteria

Time frame
The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

This trial is not recruiting at the moment. You can still explore other options: