Clinical trial NCT04561583: Effectiveness and Safety of LED Light Source System for Endoscope
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Keywords: gallstone
cholecystitis
gallbladder polyp
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visualization rate of extrahepatic bile duct.
timeFrame: During the operation
Secondary outcomes:
measure: Time of operation
timeFrame: During the operation
measure: Intraoperative blood loss
timeFrame: During the operation
measure: the occurrence rate of complications
timeFrame: Postoperative follow-up period was up to 7 days
measure: Device failure rate
timeFrame: During the operation
Other outcomes:
measure: adverse events
timeFrame: Informed to sign into the interview window 7 days after surgery
measure: serious adverse events
timeFrame: Informed to sign into the interview window 7 days after surgery
measure: device-related adverse events
timeFrame: Informed to sign into the interview window 7 days after surgery
measure: serious device-related adverse events
timeFrame: Informed to sign into the interview window 7 days after surgery
measure: device deficiency
timeFrame: During the operation
Locations:
city: Chang chun
country: China
facility: The First Affiliated Hospital of Jilin University
state: Jilin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhongtao Zhang
role: PRINCIPAL_INVESTIGATOR
References: