A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'

NCT ID: NCT02730663

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-21
• Study Completion Date: 2017-06-14

Brief Summary

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.

Detailed Description

'Niti-S SPAXUS Stent' is a newly designed lumen-apposing fully covered self-expandable metal stent. It is indicated for use in patients with pancreatic pseudocyst. Consecutive subject data should be collected at discharge, stent removal (day 30 or 60), and day 20 post Niti-S SPAXUS stent removal.

Conditions

Pancreatic Pseudocyst

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Niti-S SPAXUS Stent

Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)

Group Type: EXPERIMENTAL

Niti-S SPAXUS Stent

Intervention Type: DEVICE

Endoscopic Ultrasound-Guided Transluminal drainage

Interventions

Niti-S SPAXUS Stent

Endoscopic Ultrasound-Guided Transluminal drainage

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taewoong Medical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jong Ho Moon, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Soon Chun Hyang University

Sang Soo Lee, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Jong Kyun Lee, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Seung-Ok Lee, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Chang Min Cho, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Medical Center

Se Woo Park, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Dongtan Sacred Heart Hospital

Locations

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, South Korea

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea

Kyungpook National University Medical Center

Daegu, , South Korea

Chonbook National University Hospital

Jeonju, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

Song 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.

Reference Type: DERIVED

PMID: 31152738 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SPAXUS-001

Identifier Type: -

Identifier Source: org_study_id