CompletedNot Applicable

AXIOS CHINA (E7148)

China31 participantsStarted 2019-04-17

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age between 18 and 75 years old(including 18 and 75 years old)
✓. Eligible for endoscopic intervention
✓. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
✓. 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
✓. Patient understands the study requirements and the treatment procedures and provides written Informed Consent.
✓. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

Exclusion criteria

✕. \<18 or \>75 years of age
✕. pseudocysts or walled-off necrosis which require nasocystic drainage,or\<6cm in maximum diameter, or walled-off necrosis \< 70% fluid content
✕. The fluid collection to be drained is an immature pseudocyst
✕. The fluid collection to be drained is a cystic neoplasm
✕. The fluid collection to be drained is a pseudoaneurysm
✕. The fluid collection to be drained is a duplication cyst
✕. The fluid collection to be drained is a non-inflammatory fluid collection
✕. There is more than one pseudocyst requiring drainage

What they're measuring

Technical success rate

Timeframe: 28± 7 days post stent placement

Clinical success rate

Timeframe: 28± 7 days post stent placement

Trial details

NCT IDNCT03808272

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-24

View on ClinicalTrials.gov More Pancreatic Pseudocyst and Walled-off Necrosis trials