Safety and Effectiveness of CATHTONG™ II PICC

NCT ID: NCT03841955

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-17
• Study Completion Date: 2020-10-30

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental group

Peripheral implantation of central venous catheters and accessories with high pressure tolerance

Group Type: EXPERIMENTAL

PICC with high pressure tolerance

Intervention Type: DEVICE

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.

Control group

Peripheral intubation of central venous catheter

Group Type: EXPERIMENTAL

rontine central venous catheter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Peripheral intubation of central venous catheter

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin jingfen, Master

Role: PRINCIPAL_INVESTIGATOR

The second affiliated hosital of medical college of zhejiang university

Locations

Affiliated Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Zhejiang Provincial Tongde Hospital

Hangzhou, Zhejiang, China

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

PICC-2017-1016

Identifier Type: -

Identifier Source: org_study_id