Safety and Effectiveness of CATHTONG™ II PICC

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Device: rontine central venous catheter; Device: PICC with high pressure tolerance

• Registration Number: NCT03841955
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

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 Timeline

• Study Start: 2018-10-17
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Primary Completion: 2019-09-20
• Status Verified: 2020-06
• Study Completion: 2020-10-30
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	rontine central venous catheter	Peripheral intubation of central venous catheter
Experimental group	PICC with high pressure tolerance	Peripheral implantation of central venous catheters and accessories with high pressure tolerance

Primary Outcome Measures

Name	Time	Method
Successful rate of one-time catheterization	Day 1	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).

Secondary Outcome Measures

Name	Time	Method
success rate of one puncture.	Day 1	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.
Operating time	Day 1	The time between the beginning of disinfection of the patient's skin and the fixing of transparent dressing is in minutes.
The incidence of adverse events	about three months	Record the adverse events in the test, determine whether they are related to the test product, and calculate the incidence of adverse events/reactions.

Trial Locations

Locations (4)

Affiliated Cancer Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Zhejiang Provincial Tongde Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China