Effectiveness and Safety of LED Light Source System for Endoscope (ENV)

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Device: LED light source system for endoscope; Device: Pinpoint Endoscopic Fluorescence Imaging System

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100000
    • Beijing Chao-Yang Hospital, Capital Medical University
  • Beijing, China, 100000
    • Xuanwu Hospital, Capital Medical University
  • Jilin
    • Chang chun, Jilin, China, 130000
      • The First Affiliated Hospital of Jilin University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine

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. 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

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; 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; 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.
Other: Pinpoint Endoscopic Fluorescence Imaging System; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	Incidence (%) and frequency (number of events) of adverse events	Informed to sign into the interview window 7 days after surgery
serious adverse events	Incidence (%) and frequency (number of events) of serious adverse events	Informed to sign into the interview window 7 days after surgery
device-related adverse events	Incidence (%) and frequency (number of events) of device-related adverse events	Informed to sign into the interview window 7 days after surgery
serious device-related adverse events	Incidence (%) and frequency (number of events) of serious device-related adverse events	Informed to sign into the interview window 7 days after surgery
device deficiency	Incidence (%) and frequency (number of events) of device deficiency	During the operation

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 18, 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: gallbladder polyp; gallstone; cholecystitis
• Other Study ID Numbers: Stryker02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study Protocol will be shared
• IPD Sharing Time Frame: The clinical trial begins and ends
• IPD Sharing Access Criteria: From the beginning to the end of the clinical trial, the participating centers followed the protocol of consent
• IPD Sharing Supporting Information Type: Study Protocol

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