Effectiveness and Safety of LED Light Source System for Endoscope

Laparoscopic Cholecystectomy Clinical Trial

— ENV  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04561583
• Other study ID #: Stryker02
• Status: Withdrawn
• Phase: N/A
• Start date: September 2020
• Est. completion date: September 2021

Study information

• Verified date: April 2021
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: ?Aspartate aminotransferase AST or alanine aminotransferase ALT exceeding 3 times of the upper limit of the normal range; ? 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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing
China	The First Affiliated Hospital of Jilin University	Chang chun	Jilin
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events	Incidence (%) and frequency (number of events) of adverse events	Informed to sign into the interview window 7 days after surgery
Other	serious adverse events	Incidence (%) and frequency (number of events) of serious adverse events	Informed to sign into the interview window 7 days after surgery
Other	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
Other	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
Other	device deficiency	Incidence (%) and frequency (number of events) of device deficiency	During the operation
Primary	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	Time of operation	Time of operation	During the operation
Secondary	Intraoperative blood loss	Intraoperative blood loss	During the operation
Secondary	the occurrence rate of complications	bile duct injury, bile leakage, hemorrhage, secondary abdominal infection	Postoperative follow-up period was up to 7 days
Secondary	Device failure rate	Device failure rate	During the operation