Clinical trial · Interventional
AXIOS CHINA (E7148)
A Prospective, Multi-center, Single-arm Study to Evaluate the Safety and Efficacy of AXIOS Stent and Electrocautery-enhanced Delivery System in Chinese Patients With Pancreatic Pseudocyst and Walled-off Necrosis(WON)
NCT03808272CI-TRIAL-00071377completedN/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)
To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off necrosis in Chinese population, to support the regulatory approval by CFDA
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 |
|---|---|---|---|
| Pancreatic Pseudocyst and Walled-off Necrosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HOT AXIOS Stent and Electrocautery- Enhanced Delivery System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
- description
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
- interventionNames
- Device: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
Primary outcomes (2)
- measure
- Technical success rate
- timeFrame
- 28± 7 days post stent placement
- description
- defined as: placement of the AXIOS stent using the Electrocautery Enhanced AXIOS delivery system and removal of the AXIOS stent using a standard method: such as endoscopic snare or forceps.
- measure
- Clinical success rate
- timeFrame
- 28± 7 days post stent placement
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 75 years old(including 18 and 75 years old) 2. Eligible for endoscopic intervention 3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage 4. Diagnostic as symptomatic pancreatic pseudocysts ≥ 6cm in maximum diameter and walled-off necrosis ≥ 6cm in maximum diameter with ≥ 70% fluid content that are adherent to the gastric or bowel wall 5. Patient understands the study requirements and the treatment procedures and provides written Informed Consent. 6. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study. Exclusion Criteria: 1. \<18 or \>75 years of age 2. pseudocysts or walled-off necrosis which require nasocystic drainage,or\<6cm in maximum diameter, or walled-off necrosis \< 70% fluid content 3. The fluid collection to be drained is an immature pseudocyst 4. The fluid collection to be drained is a cystic neoplasm 5. The fluid collection to be drained is a pseudoaneurysm 6. The fluid collection to be drained is a duplication cyst 7. The fluid collection to be drained is a non-inflammatory fluid collection 8. There is more than one pseudocyst requiring drainage 9. Abnormal coagulation: INR \> 1.5 and not correctable presence of a bleeding disorder; platelets \< 50,000/mm3 10. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis). 11. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound) 12. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient. 13. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study. 14. Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
References
Publications (0)
Data not yet available
No reference posted for this study.