Objective to Evaluate the Safety and Effectiveness of LED Light Source System for Endoscopy in Ureteral Radiography (IRIS)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lower Abdominal Surgery; Pelvic Surgery
• Intervention / Treatment: Device: LED light source system for endoscope; Device: Ureteral stent (Cook Ireland Ltd.)

Detailed 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 subjects, after signing the informed consent form approved by the Ethics Committee, will be screened by the investigators. Qualified subjects who meet all the inclusion criteria and do not meet any of the exclusion criteria will be randomly divided into the control group or the test group. The subjects in the control group will accept the ureteral stent (manufacturer: Cook Ireland Ltd.) during operation. The subjects in the test group will undergo surgery using the LED light source system for endoscope and the supporting IRIS ureter kit. On the operation date, the investigators will score the performance using a scale to evaluate the resolution of the ureter in the whole process of operation. During the follow-up period, the investigators will evaluate the safety of the device based on the results of vital signs, physical examination, blood routine examination, routine urine examination, blood biochemistry, 12-lead ECG and B-mode ultrasonography of urinary system.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Xuanwu Hospital, Capital Medical University
    • Beijing, Beijing, China, 100000
      • Beijing Chao-yang Hospital,Capital Medical University
  • Changchun
    • Jilin, Changchun, China, 130000
      • The first Affiliated Hospital of Jilin University
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Obstetrics&Gynecology Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LED light source system for endoscope; 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	Device: LED light source system for endoscope; 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.
Other: Ureteral stent (Cook Ireland Ltd.); 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.)	Device: Ureteral stent (Cook Ireland Ltd.); 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 Ureteral stent (Cook Ireland Ltd.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of the ureter in the whole operation.	On the operation date, the investigators will score the performance using a scale (1 very good - 10 worst outcome) to evaluate the resolution of the ureter in the whole process of operation.	in the whole process of operation

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: rectal cancer; endometriosis; cervical cancer; adenomyosis; pelvic adhesion
• Other Study ID Numbers: Stryker03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes