Safety and Effectiveness of CATHTONG™ II PICC

A Prospective, Multicentre, Randomized, Open, Parallel Controlled Clinical Trial for Evaluating the Safety and Effectiveness of CATHTONG™ II PICC

This clinical trial is a prospective, multi-centre, open, parallel and comparative non-inferior trial design.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: PICC with high pressure tolerance; Device: rontine central venous catheter

Detailed Description

Four clinical trial institutions that meet the national qualification are selected as clinical research centers. After informed consent of the subjects and meeting the selection criteria, the subjects will be included in this clinical study. After the follow-up, all the data were sorted out and analyzed. Finally, the data of the two groups were compared to prove whether the high-pressure-resistant peripherally inserted central venous catheter developed by L&Z US, Inc. was not inferior to the control group.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Affiliated Cancer Hospital of Fudan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
    • Hangzhou, Zhejiang, China, 310000
      • Sir Run Run Shaw Hospital
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Provincial Tongde Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects volunteered to participate in the trial and signed the informed consent.
• Age 18 years old, 80 years old; gender is not limited;
• Suitable for patients who need central venous catheterization via peripheral venipuncture (life expectancy is more than 6 months): need medium-term and long-term infusion or intravenous drug therapy; need multi-chamber infusion of multiple drugs at the same time; need infusion of irritating, corrosive or hyperosmotic drugs; hyperbaric angiography or central venous pressure monitoring function;
• Patients who need to be maintained in the investigator's hospital after PICC catheterization;
• Ability to communicate well with researchers and comply with test requirements.

Exclusion Criteria:

• Local infection of puncture vein or occlusion or serious lesion of blood vessel at puncture place;
• Patients with known or suspected allergies to polyurethane;
• Pre-intubation site includes trauma history, vascular surgery history, thrombosis history, radiotherapy history, bilateral breast cancer surgery affected upper limbs, superior vena cava compression syndrome, etc.
• The prothrombin time was 6 seconds longer than the normal value and the activated partial thromboplastin time was 2.5 times longer than the normal value.
• Pregnancy and lactation women;
• The subjects had a history of difficulty in catheterization.
• Patients with pacemaker implantation in vivo;
• Researchers do not consider it appropriate to participate in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; Peripheral implantation of central venous catheters and accessories with high pressure tolerance	Device: PICC with high pressure tolerance; Subjects signed informed consent, meet the inclusion criteria and did not meet the exclusion criteria, and were randomly admitted to the experimental group and given the intervention.; Other Names: Peripheral intubation of central venous catheter
EXPERIMENTAL: Control group; Peripheral intubation of central venous catheter	Device: rontine central venous catheter; Subjects signed informed consent, meet the inclusion criteria and did not meet the exclusion criteria, and were randomly admitted to the control group and given the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful rate of one-time catheterization	Subcutaneous detection of blood vessel movements less than three times, and finally completed catheterization and confirmed that the end of the catheter in the pre-positioning proportion of the total number of patients (catheterization success refers to the chest X-ray and other fluoroscopy means to confirm that the end of the catheter is located in the middle and lower segment of superior vena cava).	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating time	The time between the beginning of disinfection of the patient's skin and the fixing of transparent dressing is in minutes.	Day 1
success rate of one puncture.	Success of one puncture refers to entering the target vein only once. If the puncture needle failed to penetrate the vein once and retreated to the subcutaneous area, then exploratory puncture was the second puncture.	Day 1
The incidence of adverse events	Record the adverse events in the test, determine whether they are related to the test product, and calculate the incidence of adverse events/reactions.	about three months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jin jingfen, Master, The second affiliated hosital of medical college of zhejiang university

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2018
• Primary Completion (ACTUAL): September 20, 2019
• Study Completion (ACTUAL): October 30, 2020

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PICC-2017-1016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No