Clinical trial · Interventional
CathiportTM Clinical Efficacy and Safety Evaluation
a Prospective, Multicenter, Randomized, Open, Parallel Controlled Noninferiority Clinical Study to Evaluate the Efficacy and Safety of CathiportTM Implantable Drug Delivery Device
NCT03198312CI-TRIAL-00028272unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Develop a prospective, multicenter, randomized, open, parallel controlled noninferiority clinical trial to evaluate the efficacy and safety of CathiportTM implantable drug delivery device
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CathiportTM | Device | — | UNRESOLVED |
| Implant Port | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CathiportTM
- description
- be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples.
- interventionNames
- Device: CathiportTM
- type
- ACTIVE_COMPARATOR
- label
- Implant Port
- description
- be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples.
- interventionNames
- Device: Implant Port
Primary outcomes (1)
- measure
- Normal usage rate of the equipment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.