Evaluation of the Safety and Efficacy of Single-use Preci... | NCT04962516

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Jul 1, 2019Actual

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jul 4, 2021

First Posted Date

Jul 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2021

Last Update Posted Date

Jul 15, 2021Actual

Name	Class
Beijing Friendship Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a pre-market clinical trial of a single-use precision filter infusion set for pumps, to evaluate the safety and effectiveness of a single-use precision filter infusion set for pumps after being used in humans, and to provide clinical evidence for the official application of the product in China

Detailed Description

This experiment compares the single-use precision filter infusion set produced by Shandong Xinhua Ande Medical Products Co., Ltd. for the same intended use that has been approved to market, and compares the performance of the two products in clinical use, the overall pass rate, and the occurrence of phlebitis Rates and adverse events are used to evaluate the safety and effectiveness of single-use precision filtration infusion sets for pumps.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group			Device: single-use precision filtered infusion sets
Control group			Device: single-use precision filter infusion set with needle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single-use precision filtered infusion sets	Device	single-use precision filter infusion set (Dalian JMS Medical Apparatus Co., Ltd.)	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vital signs	changes in breathing, resting heart rate, blood pressure, body temperature, etc	2 hr after injection
Vital signs	changes in breathing, resting heart rate, blood pressure, body temperature, etc	24 hr after injection
adverse events and complications	The incidence of adverse events and complications	2 hr after injection
adverse events and complications	The incidence of adverse events and complications	24 hr after injection
number of heat source reactions	Heat source reactions caused by the application of extension tubes, such as nausea, vomiting, chills, fever, etc., are key safety indicators	2 hr after injection
number of heat source reactions	Heat source reactions caused by the application of extension tubes, such as nausea, vomiting, chills, fever, etc., are key safety indicators	24 hr after injection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 years or older, gender not limited;
intravenous infusion requiring drug filtration, flow regulation, dosing and extension of infusion line;
not participating in other clinical trials within one month;
able to understand the purpose of the trial, voluntarily participate and sign the informed consent;
willing to follow up and evaluate according to the requirements of the trial protocol.

Exclusion Criteria:

Patients with positive pregnancy test in women of childbearing age or lactating women;
Patients with uncontrollable cardiomyopathy, heart failure and unable to tolerate infusion;
Patients with uncontrollable decompensated renal function, especially in the anuric phase of acute renal failure and unable to tolerate infusion;
Patients with uncontrollable extensive inflammation of the lung parenchyma, pulmonary congestion, pulmonary edema and unable to tolerate infusion;
0.2um size Test devices combined with any of the following drugs or preparations: fatty milk type, blood products type (blood cells, globulin, etc.), drugs that will produce insoluble precipitates with each other, etc.; 6, patients who are clinically infused with very small amounts of drugs (due to residual test line may reduce the amount of drugs delivered to patients); 7, puncture sites with inflammation, tumors, trauma, scars, etc.; 8, those who may be allergic to product materials; 9 Patients with AIDS;

10. Patients with mental disorders; 11. Other patients who are considered by the investigator to be unsuitable for participation in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Friendship Hospital		Beijing			China
Peking University Third Hospital