Safety and Effectiveness of CATHTONG™ II PICC

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841955
• Other study ID #: PICC-2017-1016
• Status: Completed
• Phase: N/A
• Start date: October 17, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: June 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 30, 2020
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial Tongde Hospital	Hangzhou	Zhejiang
China	Affiliated Cancer Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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