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Completed

NCT Number: NCT03841955

Safety and Effectiveness of CATHTONG™ II PICC

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Cancer Hospital of Fudan University, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PICC with high pressure tolerance

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.

Other names: Peripheral intubation of central venous catheter

rontine central venous catheter

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.

Primary outcomes

  1. Successful rate of one-time catheterization

    Time frame: 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 outcomes

  1. Operating time

    Time frame: Day 1

    The time between the beginning of disinfection of the patient's skin and the fixing of transparent dressing is in minutes.

  2. success rate of one puncture.

    Time frame: 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.

  3. The incidence of adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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