Robot-assisted surgeries for bladder, prostate, and renal cancer using the Micro Hand S robot
Robot-assisted Urological Surgeries Using the MicroHand S Robot: a Prospective, Single Blind, Randomized Controlled Trial
This study is testing if a new surgical robot called the Micro Hand S can perform bladder, prostate, and kidney cancer surgeries just as well as the older da Vinci robot.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital of Qingdao University Academic / other |
| Locations | 1 site (Qingdao, Shandong) |
| Trial ID | NCT05462392 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the newly developed Micro Hand S surgical robot in performing robot-assisted surgeries for bladder, prostate, and renal cancer. A total of 136 patients will be randomly assigned to undergo surgery with either the Micro Hand S robot or the established da Vinci robot. The study will assess various outcomes, including operation success rates, intraoperative complications, and surgeon satisfaction. The trial is designed to determine if the Micro Hand S robot provides non-inferior results compared to the da Vinci robot.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with bladder cancer, prostate cancer, or renal cancer who require surgical intervention.
Not a fit: Patients with a history of significant abdominal or pelvic surgeries or those with serious uncontrolled diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with access to a new surgical technology that may improve surgical outcomes and reduce complications.
How similar studies have performed: While the da Vinci robot has been widely studied and shown successful outcomes, the Micro Hand S robot is a newer technology and its effectiveness is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI was 18-30 kg/m2; * patients that need partial nephrectomy, radical cystectomy, and radical prostatectomy. * patients that understand the benefits and risks of this test, and are willing to participate and sign the informed consent form Exclusion Criteria: * Previous abdominal and pelvic surgery history (preoperative evaluation may affect this operation) * People with serious uncontrolled diseases or acute infections, including but not limited to: Patients with active tuberculosis and HIV antibody positive; Those who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose copy number of hepatitis B virus DNA (HBV-DNA) is higher than the lower limit of detection or the range of normal values; Hepatitis C virus (HCV) antibody positive; Treponema pallidum positive patients; Covid-19 positive patients * Long term use of anticoagulant and antiplatelet drugs (antiplatelet aggregation drugs were stopped less than 1 week before operation), and patients with a history of hemorrhagic diseases or hematopoietic dysfunction or coagulation dysfunction; Serious allergic constitution and suspected or confirmed alcohol, drug or drug addiction; Patients with epilepsy or mental history or cognitive impairment * Patients with cardiovascular and cerebrovascular diseases, blood system diseases, or poor control of blood glucose and blood pressure, who cannot tolerate anesthesia or increase the risk of surgery according to the evaluation of the researcher * women in pregnancy or lactation * Patients who have participated or are participating in clinical research of other drugs, biological agents or medical devices in the past 3 months * Other conditions that the researcher believes are not suitable to participate in this experiment
Where this trial is running
Qingdao, Shandong
- The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.