Safety and Effectiveness of CATHTONG™ II PICC

Zhejiang University

Status

Completed

Conditions

Cancer

Treatments

Device: rontine central venous catheter

Device: PICC with high pressure tolerance

Study type

Interventional

Funder types

Other

Identifiers

NCT03841955

PICC-2017-1016

Details and patient eligibility

About

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

Full 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.

Enrollment

144 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.