NCT04561583

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 12, 2021

Status Verified

April 1, 2021

Enrollment Period

Same day

First QC Date

September 1, 2020

Last Update Submit

April 7, 2021

Conditions

Laparoscopic Cholecystectomy

Keywords

gallstonecholecystitisgallbladder polyp

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time of operation

    During the operation

  • Intraoperative blood loss

    During the operation

  • the occurrence rate of complications

    Postoperative follow-up period was up to 7 days

  • Device failure rate

    During the operation

Other Outcomes (5)

  • adverse events

    Informed to sign into the interview window 7 days after surgery

  • serious adverse events

    Informed to sign into the interview window 7 days after surgery

  • device-related adverse events

    Informed to sign into the interview window 7 days after surgery

  • +2 more other outcomes

Study Arms (2)

LED light source system for endoscope

OTHER

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

Pinpoint Endoscopic Fluorescence Imaging System

OTHER

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

Interventions

LED light source system for endoscopeDEVICE

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.

LED light source system for endoscope
Pinpoint Endoscopic Fluorescence Imaging SystemDEVICE

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The First Affiliated Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, 100000, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, 100000, China

Location

MeSH Terms

Conditions

GallstonesCholecystitis

Interventions

Endoscopes

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • Zhongtao Zhang

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In this trial, single-blind method will be used, which means that the investigators know about the device used for treatment of the subjects while the subjects know nothing about it.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 23, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2021

Last Updated

April 12, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Study Protocol will be shared

Shared Documents
STUDY PROTOCOL
Time Frame
The clinical trial begins and ends
Access Criteria
From the beginning to the end of the clinical trial, the participating centers followed the protocol of consent

Locations

CN(4)