Ureteral StrictureROBUST-C1000NCT06983067
Application of the Sentire C1000 for Ureteral Stricture Repair
An observational study of Ureteral Stricture and Hydronephrosis, run by Xuesong Li at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ureteral Stricture, Hydronephrosis
- What is being tested?
- Cornerstone C1000 Robotic Surgery System
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- (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.
Who cannot join
- (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).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Xuesong Li Prof., M.D., +86-01083572845, 378119532@qq.com
About this study
Official title: A Prospective, Open-label, Single-Arm Study Evaluating the Sentire C1000 Surgical Robotic System in Ureteral Reconstruction for Benign Ureteral Strictures
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.
Read more
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.
Read the detailed description
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)
- Conditions
- Ureteral Stricture, Hydronephrosis
- Being tested
- Cornerstone C1000 Robotic Surgery System
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cornerstone C1000 Robotic Surgery SystemDevice
Minimally invasive surgical instruments are controlled by the physician using a master-slave operating system for urologic laparoscopic surgical operations.
| Study group | Role | What they receive |
|---|---|---|
| Simple anastomosis reconstruction group | Including pyeloplasty, stenectomy and reanastomosis, and bladder reimplantation Receives: Device: Cornerstone C1000 Robotic Surgery System | |
| Patch Repair Group | Includes oral mucosa, appendix patches, etc. Receives: Device: Cornerstone C1000 Robotic Surgery System | |
| Intestinal/ileal Substitute Ureteral Group | These include the ileal substitution ureter and colonic substitution ureter procedures. Receives: Device: Cornerstone C1000 Robotic Surgery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 3 months postoperatively
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 May 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuesong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuesong Li, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983067
- Sponsor's protocol ID
- F-00882-001
- Acronym
- ROBUST-C1000
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No