Application of the Sentire C1000 for Ureteral Stricture Repair
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXuesong Li
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(1) Patients aged ≥18 years and ≤80 years, male or 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 who voluntarily participate in the clinical trial and agree or whose guardians agree and sign the informed consent form; (5) Willing to cooperate and complete the trial follow-up and related examinations.
Disqualifiers
(1) Presence of severe drug/imaging contrast allergy; (2) Patients with a history of pelvic/abdominal surgery and assessed for extensive severe adhesions; (3) Those with a previous history of other malignancies and judged by the investigator to be unsuitable for enrollment; (4) Diseases that are not expected to tolerate pneumoperitoneum or prolonged head-down-foot-up position, or diseases that do not allow intraoperative positioning, such as spinal deformity or ankylosing spondylitis; (5) Those with serious comorbidities (heart, lung, liver, brain, kidney and other diseases) and those who are physically weak and cannot tolerate general anesthesia or surgery; (6) Those with serious bleeding tendency or coagulation disorders; (7) Patients who have been using anticoagulant or antiplatelet aggregating drugs for a long time, or those who have stopped using anticoagulant or antiplatelet aggregating drugs for less than 1 week before surgery (except for the prophylactic use of low molecular heparin before surgery); (8) Patients with active infectious diseases or other severe non-infectious infections; (9) Those who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (Hepatitis B) or Hepatitis C Surface Antigen (Hepatitis C).
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cornerstone C1000 Robotic Surgery System
DeviceMinimally invasive surgical instruments are controlled by the physician using a master-slave operating system for urologic laparoscopic surgical operations.
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Simple anastomosis reconstruction group1 intervention
Group B: Patch Repair Group1 intervention
Group C: Intestinal/ileal Substitute Ureteral Group1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
During the surgery2
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 postoperativelySecondary outcomes
1
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 surgery2
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 surgery3
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 surgery4
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 surgeryOther outcomes
1
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).
Time frame
3 months postoperatively2
Adverse events
To evaluate the type, incidence (%), and frequency (number of events) of adverse events and device-related adverse events during the study period.
Time frame
3 months postoperatively3
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.
Time frame
3 months postoperatively4
Instrument defects
To evaluate the type, incidence (%), and frequency (number of events) of device defects during the study period.
Time frame
During the surgerySponsors and contacts
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Xuesong Li
Lead sponsor
Peking University First Hospital
Sponsor institution
Source ClinicalTrials.gov