Clinical trial · Interventional
Objective to Evaluate the Safety and Effectiveness of LED Light Source System for Endoscopy in Ureteral Radiography
A Prospective, Multi-center, Single-blind, Parallel, Randomized Controlled Clinical Trial (IRIS) Designed to Evaluate the Safety and Effectiveness of the LED Light Source System for Endoscope During Ureter Transillumination
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was registered but never started.
Summary
Brief summary (as posted)
This clinical trial is a prospective, multi-center, single-blind, parallel, randomized controlled superiority clinical trial. The trial will be carried out in 5 centers, involving 120 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 60 subjects). This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and candidates are screened; after screening, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device tested; safety follow-up visit is carried out during the follow-up period.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lower Abdominal Surgery | — | UNRESOLVED | — |
| Pelvic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LED light source system for endoscope | Device | — | UNRESOLVED |
| Ureteral stent (Cook Ireland Ltd.) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- LED light source system for endoscope
- description
- The prospective, multi-center, single-blind, parallel, randomized controlled superiority trial design is adopted to evaluate the safety and effectiveness of the LED light source system for endoscope during ureter transillumination. The trial will be carried out in 5 centers, with the competitive grouping mode adopted. This trial will be carried out in the General Surgery Department and the Gynecology Department. Totally 120 subjects with rectal cancer, endometriosis, cervical cancer, adenomyosis and pelvic adhesion requiring operation (60 subjects for each of the test group and control group) are involved. The test group use LED light source system for endoscope
- interventionNames
- Device: LED light source system for endoscope
- type
- OTHER
- label
- Ureteral stent (Cook Ireland Ltd.)
- description
- The prospective, multi-center, single-blind, parallel, randomized controlled superiority trial design is adopted to evaluate the safety and effectiveness of the LED light source system for endoscope during ureter transillumination. The trial will be carried out in 5 centers, with the competitive grouping mode adopted. This trial will be carried out in the General Surgery Department and the Gynecology Department. Totally 120 subjects with rectal cancer, endometriosis, cervical cancer, adenomyosis and pelvic adhesion requiring operation (60 subjects for each of the test group and control group) are involved. The control group use Ureteral stent (Cook Ireland Ltd.)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
1. Inclusion Criteria: 1. The surgeon believes preventative placement of a ureteral stent is necessary and the target organ to be excised in the surgery is closely related to the ureter (e.g. representative specialized operations such as rectal cancer and endometriosis, cervical cancer, adenomyosis and pelvic adhesion). 2. Age: 18 to 80 years old; 3. All subjects voluntarily participate in the clinical trial and are asked to sign the informed consent form. 2. Exclusion Criteria: 1. Women during pregnancy or lactation; 2. Subjects are involved in other clinical trials at the same time; Hydronephrosis due to urinary tract obstruction; Laparotomy is expected (except for conversion to laparotomy during operation); 3. Other conditions deemed by the investigators as unsuitable for operation; 4. Other conditions deemed by the investigators as unsuitable for the trial (including anticipated catheterizing failure).
References
Publications (0)
Data not yet available