Clinical trial · Interventional
Safety and Efficacy of an Ablation Catheter for the Treatment of Pancreatic Premalignant Cyctic Lesions.
A Prospective, Open Label Study: Safety and Efficacy of a New Ablation Catheter RFA (Radiofrequency Under EUS) Developed by TAEWOONG Company for the Treatment of Pancreatic Premalignant and Early Malignant Cyctic Lesions.
NCT03417843CI-TRIAL-00031656yesunknownN/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)
This study aims to evaluate the safety and efficacy of new ablation catheter developed by MEDICAL TAEWOONG for the treatment of pancreatic premalignant and early malignant cystic lesion. The ablation is performed using EUSRA needle and radiofrequncy waves under ultrasound imaging. The method will be exaimened on patients who are candidates for surgical intervention and to examine the ability of the method to serve as an alternative to surgical intervention.
Conditions
Conditions (4)
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 Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer Stage | — | UNRESOLVED | — |
| Pancreatic Cyst | — | UNRESOLVED | — |
| Pancreatic Neuroendocrine Tumor | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUSRA RF electrode | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EUSRA RF electrode
- description
- new ablation catheter RFA (RADIOFREQUENCY under EUS), developed by TAEWOONG company for the treatment of pancreatic premalignant and early malignant cystic lesion.
- interventionNames
- Device: EUSRA RF electrode
Primary outcomes (5)
- measure
- Incidence of adverse and serious adverse events
- timeFrame
- up to one month post-procedure
- description
- The number of subjects with post EUS-RFA-related adverse events including: Fever \>38C (will be measured in celcius)
- measure
- Incidence of adverse and serious adverse events
- timeFrame
- up to 72 hours post-procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18-85 • Patients who agreed to join study and signed an informed consent letter * Patients with IPMN pancreas cystic tumor with a diameter greater than 30 mm and with secondary branches. * Patients with a tissue component within the cystic lesion * Patients with atypical cells in cytology, regardless of the size of the lesion and regardless of the contents of the cyst * Patients with a lesion of less than 30 mm diameter showing rapid changes in size (15 mm increments followed by 6 months) * Patients with a consistent increase in CEA level within the cyst. * Patients with cystinus cystadenoma of any size with suspicious signs such as thickening of the cyst wall, calcification of the cyst wall, irregularity of the cyst wall, tissue content within the cyst, the presence of atypical cells within the cyst in cytology. * Symptomatic patients (pain defined as related to the lesion) * Asymptomatic patients with a normal cyst greater than 40 mm in diameter. * Patients referred for surgical treatment (after the multidisciplinary committee (gastroenterologists, surgeons and pathologists / cytologists) has approved the diagnosis and indication of therapeutic intervention (as is customary) but not suitable for surgery due to high risk of anesthesia (ASAIV) or severe anatomy due to repeat surgery or patients who do not agree to undergo surgical intervention (these are most patients) * Patients with low anesthetic risk: ASA 1-3. * Women who are not pregnant during recruitment, and women of childbearing age who take birth control during the study. Exclusion Criteria: * Patients with clear evidence of invasive tumor development within the lesion (both candidates and not candidates for continued surgical treatment). * Patients with severe coagulation disorders (PT, elongated PTT) * Patients with platelet counts less than 75000 * Patients taking anticoagulants that can not be stopped temporarily * Patients with pacemakers * Patients with dilatation pages * Patients who take clopidogrel in situations that do not allow temporary cessation of the drug. * Patients with hight anesthetic risk(ASA4 group). * Patients belonging to groups: pregnant women, nursing patients, and demineral patients. * Women of childbearing age who do not take birth control. * Patients who are unable to express informed consent.
References
Publications (20)
- BACKGROUNDHammel P. [Incidental pancreatic tumors: diagnosis and management]. Gastroenterol Clin Biol. 2002 Aug-Sep;26(8-9):700-8. No abstract available. French. PMID 12434071
- BACKGROUNDBrugge WR, Lewandrowski K, Lee-Lewandrowski E, Centeno BA, Szydlo T, Regan S, del Castillo CF, Warshaw AL. Diagnosis of pancreatic cystic neoplasms: a report of the cooperative pancreatic cyst study. Gastroenterology. 2004 May;126(5):1330-6. doi: 10.1053/j.gastro.2004.02.013. PMID 15131794
- BACKGROUNDOkabayashi T, Kobayashi M, Nishimori I, Sugimoto T, Namikawa T, Okamoto K, Okamoto N, Kosaki T, Onishi S, Araki K. Clinicopathological features and medical management of intraductal papillary mucinous neoplasms. J Gastroenterol Hepatol. 2006 Feb;21(2):462-7. doi: 10.1111/j.1440-1746.2005.03958.x. PMID 16509876
- BACKGROUNDMatsumoto T, Aramaki M, Yada K, Hirano S, Himeno Y, Shibata K, Kawano K, Kitano S. Optimal management of the branch duct type intraductal papillary mucinous neoplasms of the pancreas. J Clin Gastroenterol. 2003 Mar;36(3):261-5. doi: 10.1097/00004836-200303000-00014. PMID 12590239
- BACKGROUNDGan SI, Thompson CC, Lauwers GY, Bounds BC, Brugge WR. Ethanol lavage of pancreatic cystic lesions: initial pilot study. Gastrointest Endosc. 2005 May;61(6):746-52. doi: 10.1016/s0016-5107(05)00320-2. PMID 15855986
- BACKGROUNDOh HC, Seo DW, Lee TY, Kim JY, Lee SS, Lee SK, Kim MH. New treatment for cystic tumors of the pancreas: EUS-guided ethanol lavage with paclitaxel injection. Gastrointest Endosc. 2008 Apr;67(4):636-42. doi: 10.1016/j.gie.2007.09.038. Epub 2008 Feb 11. PMID 18262182
- BACKGROUNDDeWitt J, McGreevy K, Schmidt CM, Brugge WR. EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study. Gastrointest Endosc. 2009 Oct;70(4):710-23. doi: 10.1016/j.gie.2009.03.1173. Epub 2009 Jul 4.