Effectiveness and Safety of LED Light Source System for Endoscope
Effectiveness and Safety of LED Light Source System for Endoscope
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.
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.
1. Inclusion Criteria:

 1. Subjects who should receive laparoscopic cholecystectomy on a selected day
 Symptoms of such subjects include gallstone, cholecystitis, or gallbladder
 polyp≥0.8 cm

 2. Aged between 18 and 75

 3. All subjects voluntarily participate in the clinical trial and are asked to sign
 the informed consent form

 2. Exclusion Criteria:

 1. Subjects suffering acute cholecystitis and cholangitis

 2. Subjects requiring laparotomy

 3. Women during pregnancy or lactation

 4. Subjects expected to give birth to a child within 3 months after the trial

 5. Subjects suffering liver cirrhosis

 6. Subjects allergic to ICG or iodine

 7. Subjects with cardiopulmonary insufficiency and those intolerant of surgery

 8. 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

 9. Subjects with history of malignant cancer or subjects with malignant cancer

 10. Subjects currently engaged in other clinical trials

 11. Subjects deemed by the investigators as unsuitable for the trial