The purpose of this clinical study is to evaluate the safety and efficacy of the Sten® Laparoendoscopic Surgical System C1000 for benign ureteral reconstruction surgery. This is a single-arm, open-label, prospective, non-randomized cohort study. Eligibility criteria for recruitment to this study included how to include labeling: (1) patients aged ≥18 years and ≤80 years, male and female; (2) patients who need to undergo upper urinary tract repair surgery; (3) patients who are suitable for ureteral reconstruction surgery as confirmed by the investigator; (4) subjects voluntarily participating in the clinical trial and agreeing to, or their guardian agreeing to, and signing an informed consent form; (5) willingness to cooperate with and complete the trial follow-up and related examinations. The research subjects of this project were recruited openly, and the patients were enrolled after being informed of the study-related information, risks and benefits by the project participants and then screened to meet the enrollment criteria. A total of 50 patients will be enrolled. The study objectives and endpoints include the following: primary endpoints: (1) the rate of surgical non-referral (2) the success rate of surgical treatment; secondary endpoints: (1) the loading time (2) the operating time of the surgeon (3) the estimated intraoperative blood loss (4) the postoperative patient's pain scores (5) the evaluation of the physiological load of the surgeon (6) the evaluation of the mental load of the surgeon (7) the rate of intraoperative transfusion (8) the duration of the hospital stay after the operation (9) the evaluation of physician satisfaction (9) the evaluation of physician's satisfaction). (9) Physician satisfaction rating (10) Overall postoperative complication rate (11) Adverse events and serious adverse events (12) Device defects (13) Postoperative readmission rate (14) Reoperation rate (15) Mortality rate. The expected overall duration is 9 months, with an expected enrollment time of 6 months and a subject follow-up time of approximately 3 months.
The purpose of this clinical study is to evaluate the safety and efficacy of the Sten® Laparoendoscopic Surgical System C1000 for benign ureteral reconstruction surgery. This is a single-arm, open-label, prospective, non-randomized cohort study. Eligibility criteria for recruitment to this study included how to include labeling: (1) patients aged ≥18 years and ≤80 years, male and female; (2) patients who need to undergo upper urinary tract repair surgery; (3) patients who are suitable for ureteral reconstruction surgery as confirmed by the investigator; (4) subjects voluntarily participating in the clinical trial and agreeing to, or their guardian agreeing to, and signing an informed consent form; (5) willingness to cooperate with and complete the trial follow-up and related examinations. The research subjects of this project were recruited openly, and the patients were enrolled after being informed of the study-related information, risks and benefits by the project participants and then screened to meet the enrollment criteria. A total of 50 patients will be enrolled. The study objectives and endpoints include the following: primary endpoints: (1) the rate of surgical non-referral (2) the success rate of surgical treatment; secondary endpoints: (1) the loading time (2) the operating time of the surgeon (3) the estimated intraoperative blood loss (4) the postoperative patient's pain scores (5) the evaluation of the physiological load of the surgeon (6) the evaluation of the mental load of the surgeon (7) the rate of intraoperative transfusion (8) the duration of the hospital stay after the operation (9) the evaluation of physician satisfaction (9) the evaluation of physician's satisfaction). (9) Physician satisfaction rating (10) Overall postoperative complication rate (11) Adverse events and serious adverse events (12) Device defects (13) Postoperative readmission rate (14) Reoperation rate (15) Mortality rate. The expected overall duration is 9 months, with an expected enrollment time of 6 months and a subject follow-up time of approximately 3 months. Translated with www.DeepL.com/Translator (free version)
Study Type
OBSERVATIONAL
Enrollment
50
Minimally invasive surgical instruments are controlled by the physician using a master-slave operating system for urologic laparoscopic surgical operations.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGSurgical non-transfer rate
Surgical non-transfer rate is defined as failure to switch from the test medical device (Laparoendoscopic Surgical System) assisted approach to other surgical device control system assisted, laparoscopic surgery or open surgery. Surgical non-referral rate = number of subjects whose surgery was not referred/total number of subjects x 100%.
Time frame: During the surgery
Success rate of surgical treatment
At 3 months postoperatively, surgical treatment was considered successful when the following conditions were also met: * No ureteral obstruction on investigator-assessed imaging and no deterioration/progression of renal function from baseline. * No interventions (endoluminal dilatation, surgical interventions, etc.) for disease progression or recurrence after study treatment, except for interventions for complications of the surgery Success rate of surgical treatment = number of subjects with successful surgical treatment/total number of subjects × 100%.
Time frame: 3 months postoperatively
Installation time
Defined as starting with the push of the patient-side robot and pushing to the bedside until all arms are aligned with the cannula and the arms are adjusted to the proper position. Unit: minutes.
Time frame: During the surgery
Surgeon operating time
Defined as the time from the first effective movement of the arm by the surgeon until the surgeon completes the surgical procedure and the arm stops moving (excluding pause time due to force majeure). Unit: minutes. The starting point of the operation time: the first effective movement of the operating arm controlled by the surgeon; the end point: the surgeon completes the surgical operation and the movement of the operating arm stops.
Time frame: During the surgery
Estimated blood loss
Defined as intraoperative blood loss, i.e., the estimated total blood loss from the time the test medical device enters the body cavity incision to the completion of the surgical incision suture, including the blood volume in the suction bottle and intraoperative gauze, etc., and excluding intraoperative irrigation fluid or perfusion fluid, etc., with 1g counted as 1mL. unit: mL.
Time frame: During the surgery
Postoperative patient pain scores
At the screening/baseline period, at the 24±4h postoperative follow-up, and at the 3-month postoperative follow-up, subjects were assessed for postoperative pain according to a visual analogue scale (VAS) ranging from a score of 0 (no pain) to a score of 10 (maximum pain).
Time frame: During the surgery
Evaluation of intraoperative physiologic load by the surgeon
On the day of surgery, the Localized Discomfort Experience Scale was taken to evaluate the surface electromyography of the muscles of the shoulder, neck, upper extremity, and lumbar region. Calculation formula: the primary surgeon's intraoperative physiologic load score = the sum of the primary surgeon's intraoperative physiologic load score for all subjects ÷ the number of cases of subjects undergoing surgical treatment.
Time frame: During the surgery
Wise Load Evaluation of the Surgeon
On the day of surgery, the Subjective Mental Load Scale was taken for evaluation. Calculation formula: subjective surgeon's surgical mental load score = sum of all subjects' subjective surgeon's surgical mental load scores ÷ number of cases of subjects undergoing surgical treatment.
Time frame: During the surgery
Intraoperative blood transfusion rates
Defined as the number of subject cases requiring blood transfusion as a percentage of the total number of subject cases from the first surgical incision to the completion of suturing of the last surgical incision.
Time frame: During the surgery
Post-operative hospitalization time
Defined as the total number of days the subject was hospitalized from the day of surgery to discharge, which was recorded at follow-up.
Time frame: Perioperative period
Physician satisfaction ratings
The investigators rated the performance and comfort level of the test medical devices through a questionnaire after completing the procedure.
Time frame: During the surgery
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