Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT03198312
Eligibility Criteria:
Inclusion Criteria:
1. Older than 18 years old;
2. Need for long-term intravenous fluids;
3. Lack of peripheral venous access ;
4. Need stimulants infusion, such as chemotherapy drugs;
5. Need infusion of high permeability or sticky liquid, such as parenteral nutrient solution, fat emulsion;
6. Need repeated blood or blood products transfusion and repeated blood collection;
7. Fit and need implanted Port;
8. Willing to participate in clinical research and signed informed consent;
Patient meet 1 and 8 firstly, and then meet any one item with 2-7 above can be accepted.
Exclusion Criteria:
1. Cancer patients whose vascular related to the surgery is compressed ;
2. Women patients with pregnancy and lactation;
3. Participate other studies before achieving the primary end point already;
4. Confirmed or suspected catheter-related infections, disseminated intravascular coagulation, bacteremia, sepsis;
5. Body size is not suitable for implanting the infusion port ;
6. Confirmed or suspected allergic to silicone material;
7. Having a history of radiation therapy at the pre-implant site;
8. Having occurred acute myocardial infarction within 1 week or stroke in the past 6 months;
9. Having a history of venous thrombosis, trauma, or vascular surgery;
10. Superior vena cava syndrome;
11. Having poor compliance behavior;
12. Having installed the cardiac pacemaker device, bypass, accepted heart transplant or diagnosed with kidney failure（GFR≤30ml/Min）.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03198312
Study Brief:
Protocol Section:
NCT03198312