Effectiveness and Safety of LED Light Source System for Endoscope

Study Overview
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Brief Summary
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This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 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 inclusion and exclusion criteria are verified; after that, 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; safety follow-up visit is carried out during the follow-up period.

Detailed Description
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The prospective, multi-center, single-blind, parallel, randomized controlled non-inferiority trial design is adopted to evaluate the safety and effectiveness of the real-time endoscopic near infrared fluorescence image provided by the LED light source system for endoscope by evaluating at least one main extrahepatic bile duct (common bile duct and ductuli hepaticus communis). The trial will be carried out in 5 centers, with the competitive grouping mode adopted. Totally 220 patients to receive laparoscopic cholecystectomy will be involved (110 patients for each of the control group and the test group). 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. For the subjects in the control group, the Pinpoint Endoscopic Fluorescence Imaging System commercially available will be used for operation. For subjects of the test group, the LED light source system for endoscope will be used for operation. On the operation date, investigators will evaluate the display performance of the device by judging whether at least one main extrahepatic bile duct (common bile duct and ductuli hepaticus communis) is displayed. 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 and 12-lead ECG.

Official Title
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A Prospective, Multi-center, Single-blind, Parallel, Randomized Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the LED Light Source System for Endoscope During Ureter Transillumination.

Conditions
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Laparoscopic Cholecystectomy

Intervention / Treatment
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* Device: LED light source system for endoscope
* Device: Pinpoint Endoscopic Fluorescence Imaging System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who should receive laparoscopic cholecystectomy on a selected day Symptoms of such subjects include gallstone, cholecystitis, or gallbladder polyp≥0.8 cm Aged between 18 and 75 All subjects voluntarily participate in the clinical trial and are asked to sign the informed consent form Exclusion Criteria: Subjects suffering acute cholecystitis and cholangitis Subjects requiring laparotomy Women during pregnancy or lactation Subjects expected to give birth to a child within 3 months after the trial Subjects suffering liver cirrhosis Subjects allergic to ICG or iodine Subjects with cardiopulmonary insufficiency and those intolerant of surgery Subjects with abnormal renal and liver function: ①Aspartate aminotransferase AST or alanine aminotransferase ALT exceeding 3 times of the upper limit of the normal range; ② Serum creatinine > 2.0 mg/dL or ≥ 176.8 μmol/L Subjects with history of malignant cancer or subjects with malignant cancer Subjects currently engaged in other clinical trials Subjects deemed by the investigators as unsuitable for the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 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 inclusion and exclusion criteria are verified; after that, 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; safety follow-up visit is carried out during the follow-up period.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LED light source system for endoscope<br>This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).Test grop use LED light source system for endoscope | Device: LED light source system for endoscope<br>* This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 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 inclusion and exclusion criteria are verified; after that, 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; safety follow-up visit is carried out during the follow-up period.<br>|
| Other: Pinpoint Endoscopic Fluorescence Imaging System<br>This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).control group use Pinpoint Endoscopic Fluorescence Imaging System (Model: PC9000) | Device: Pinpoint Endoscopic Fluorescence Imaging System<br>* This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 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 inclusion and exclusion criteria are verified; after that, 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; safety follow-up visit is carried out during the follow-up period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization rate of extrahepatic bile duct. | Note: The visualization rate of extrahepatic bile duct refers to the visualization rate of at least one extrahepatic bile duct (the ductuli hepaticus communis and common bile duct) after dissection of the calot's triangle (the images are taken respectively before unfolding the anatomical structure, during dissection and after complete unfolding of the triangular structure). | During the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of operation | Time of operation | During the operation | 
| Intraoperative blood loss | Intraoperative blood loss | During the operation | 
| the occurrence rate of complications | bile duct injury, bile leakage, hemorrhage, secondary abdominal infection | Postoperative follow-up period was up to 7 days | 
| Device failure rate | Device failure rate | During the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gallstone, cholecystitis, gallbladder polyp