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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simple anastomosis reconstruction group | Including pyeloplasty, stenectomy and reanastomosis, and bladder reimplantation |
| |
| Patch Repair Group | Includes oral mucosa, appendix patches, etc. |
| |
| Intestinal/ileal Substitute Ureteral Group | These include the ileal substitution ureter and colonic substitution ureter procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cornerstone C1000 Robotic Surgery System | Device | Minimally invasive surgical instruments are controlled by the physician using a master-slave operating system for urologic laparoscopic surgical operations. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical 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%. | During the surgery |
| Success rate of surgical treatment | At 3 months postoperatively, surgical treatment was considered successful when the following conditions were also met:
| 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the surgery |
| Surgeon operating time |
| Measure | Description | Time Frame |
|---|---|---|
| Overall complication rate at 3 months postoperatively | Complications were recorded from the first intraoperative incision to the 3-month postoperative follow-up, and the overall complication rate was evaluated by the Clavien-Dindo grading system (Clavien-Dindo grading of 1 or higher). | 3 months postoperatively |
| Adverse events |
Inclusion Criteria:
Exclusion Criteria:
Hepatitis B Surface Antigen (HbsAg)-positive, Hepatitis C Virus (HCV)-positive, and syphilis-positive patients; (10) Persons with severe allergies, suspected or confirmed alcohol, drug or drug addiction; (11) Those with a history of epilepsy or psychosis or with cognitive impairment; (12) Women who are pregnant, breastfeeding, or planning to become pregnant during the trial, or male or female patients who do not wish to use barrier contraception during the trial; (13) Participation in any other clinical trial (except non-interventional trials) within 3 months prior to signing the informed consent form, planning to undergo any other major surgical procedure during the trial, or inability to recover from the side effects of a previous procedure; (14) Any other circumstances that the investigator considers inappropriate for participation in this clinical trial.
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Eligibility criteria for enrollment in 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 as confirmed by the investigator; (4) subjects voluntarily participating in the clinical trial and agreeing to, or whose guardian agrees to, and signing an informed consent form; (5) willingness to cooperate with and complete the trial follow-up and related examinations.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D006869 | Hydronephrosis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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. |
| 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. | 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). | 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. | 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. | 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. | 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. | 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. | During the surgery |
To evaluate the type, incidence (%), and frequency (number of events) of adverse events and device-related adverse events during the study period. |
| 3 months postoperatively |
| Serious adverse event | To evaluate the type, incidence (%), and frequency (number of events) of serious adverse events and device-related serious adverse events during the study period. | 3 months postoperatively |
| Instrument defects | To evaluate the type, incidence (%), and frequency (number of events) of device defects during the study period. | During the surgery |
| Post-operative readmission rate | To evaluate the incidence (%) and frequency of readmission from the time the subject was discharged to 3 months postoperatively. | 3 months postoperatively |
| Reoperation rate | The incidence (%) and frequency of reoperation within 3 months after surgery were evaluated. | 3 months postoperatively |
| Mortality rate | To evaluate the incidence (%) and frequency of subject deaths within 3 months postoperatively. | 3 months postoperatively |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |