Clinical trial · Interventional
A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'
A Prospective, Multi-center, Single Arm, Non-inferiority, Open-label, Pivotal Study to Evaluate the Effectiveness and Safety of EUS -Guided Transluminal Drainage With 'Niti-S SPAXUS Stent' for the Treatment of Pancreatic Pseudocyst
NCT02730663CI-TRIAL-00040643completedN/AResults postedClinicalTrials.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)
The purpose of this study is to evaluate the safety and effectiveness of endoscopic ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment of pancreatic pseudocyst.
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 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Niti-S SPAXUS Stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Niti-S SPAXUS Stent
- description
- Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)
- interventionNames
- Device: Niti-S SPAXUS Stent
Primary outcomes (1)
- measure
- Number of Participants With Clinical Success
- timeFrame
- at stent removal (Day 30 or Day 60)
- description
- Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)
Secondary outcomes (6)
- measure
- Number of Participants With Technical Success
- timeFrame
- Day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Pancreatic pseudocyst ≥6cm in size, with ≥70% fluid content that is eligible for transluminal drainage * Patient willing to provide written informed consent and comply with follow-up requirements Exclusion Criteria: * Ineligible for endoscopic intervention * Pancreatic pseudocyst with severe internal septation * Platelet count \< 60,000 cells/mm3 or international normalized ratio (INR) \>1.5 * Hemodynamic instability (e.g. shock) * Active infectious disease (e.g. endocarditis, meningitis) * Participating in any other investigational drug or device clinical trial within past 3 months * Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant
References
Publications (1)
- DERIVEDSong TJ, Lee SS, Moon JH, Choi HJ, Cho CM, Lee KH, Park SW, Kim SH, Lee SO, Lee YN, Lee JK. Efficacy of a novel lumen-apposing metal stent for the treatment of symptomatic pancreatic pseudocysts (with video). Gastrointest Endosc. 2019 Sep;90(3):507-513. doi: 10.1016/j.gie.2019.05.033. Epub 2019 May 30. PMID 31152738