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

NCT02730663 | Completed Results DMC

• 1 other identifier: SPAXUS-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

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.

Conditions

Pancreatic Pseudocyst

Keywords

Endoscopic ultrasound guided transluminal drainage

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Success

  Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)

  at stent removal (Day 30 or Day 60)

Secondary Outcomes (6)

• Number of Participants With Technical Success

  Day 1

• Number of Participants With Stent Lumen Patency

  up to 60 days (at stent removal, Day 30 or 60)

• Number of Participants With Stent Removal Success

  up to 60 days (at stent removal, Day 30 or 60)

• Procedure Time

  1 day

• Number of Participants With Procedural/Device Related Serious Adverse Events

  up to 90 days (at Day 20 post stent removal)

Study Arms (1)

Niti-S SPAXUS Stent

EXPERIMENTAL

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

Device: Niti-S SPAXUS Stent

Interventions

Niti-S SPAXUS Stent DEVICE

Endoscopic Ultrasound-Guided Transluminal drainage

Niti-S SPAXUS Stent

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taewoong Medical Co., Ltd.: lead

Study Sites (6)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, 14584, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

Location

Kyungpook National University Medical Center

Daegu, 41404, South Korea

Location

Chonbook National University Hospital

Jeonju, 54907, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31152738 DERIVED

MeSH Terms

Conditions

Pancreatic Pseudocyst

Condition Hierarchy (Ancestors)

Pancreatic Cyst; Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Results Point of Contact

• Title: JiYoung Ahn/Assistant manager
• Organization: Taewoong Medical Co., Ltd.

sarahahn@stent.net

+82-70-4649-1624

Study Officials

• Jong Ho Moon, PhD, MD

  Soon Chun Hyang University

  PRINCIPAL INVESTIGATOR

• Sang Soo Lee, PhD, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Jong Kyun Lee, PhD, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Seung-Ok Lee, PhD, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• Chang Min Cho, PhD, MD

  Kyungpook National University Medical Center

  PRINCIPAL INVESTIGATOR

• Se Woo Park, PhD, MD

  Hallym University Dongtan Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The investigational device (ID) 'Niti-S SPAXUS Stent' is used for drainage of cystic fluid by being connected to the pancreatic pseudocyst through human organs such as stomach or duodenum. It is composed with a stent made of nitinol and introducer system.

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 6, 2016
• Study Start: March 21, 2016
• Primary Completion: June 14, 2017
• Study Completion: June 14, 2017
• Last Updated: September 17, 2019
• Results First Posted: July 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)