Clinical trial NCT03841955: Safety and Effectiveness of CATHTONG™ II PICC
Official title: A Prospective, Multicentre, Randomized, Open, Parallel Controlled Clinical Trial for Evaluating the Safety and Effectiveness of CATHTONG™ II PICC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Successful rate of one-time catheterization
timeFrame: Day 1
Secondary outcomes:
measure: Operating time
timeFrame: Day 1
measure: success rate of one puncture.
timeFrame: Day 1
measure: The incidence of adverse events
timeFrame: about three months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Affiliated Cancer Hospital of Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Tongde Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: The second affiliated hosital of medical college of zhejiang university
name: Jin jingfen, Master
role: PRINCIPAL_INVESTIGATOR
References: