Status:
COMPLETED
Safety and Effectiveness of CATHTONG™ II PICC
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03841955
Start Date
October 17 2018
End Date
October 30 2020
Last Update
June 16 2021
Active Locations (4)
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1
Affiliated Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, China
2
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000
3
Zhejiang Provincial Tongde Hospital
Hangzhou, Zhejiang, China, 310000
4
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009