AXIOS Stent & Delivery System Study

NCT01419769 | Completed Results DMC

• 1 other identifier: CD00744
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 7

Brief Summary

The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA). The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized) study. Up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States. Patients will be followed at (approximately) 30 days and/or 60 days depending upon pseudocyst resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6 month post-stent removal.

Conditions

Pancreatic Pseudocyst(s)

Keywords

symptomatic pancreatic pseudocyst; pancreatic pseudocyst; transluminal drainage; minimally invasive; Nitinol stent; transmural endoscopic drainage; catheter based

Outcome Measures

Primary Outcomes (6)

• Safety - Freedom From Major Complications: Access Site-related Bleeding

  Subjects are free of access site-related bleeding requiring transfusion

  Through the duration of the 1-week post-stent removal study period

• Safety - Freedom From Major Complications: Access Site-related Infection

  Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization

  Through the duration of the 1-week post-stent removal study period

• Safety - Freedom From Major Complications: Perforation

  Subjects are free of surgery for access-site related perforation

  Through the duration of the 1-week post-stent removal study period

• Safety - Freedom From Major Complications: Stent Migration/Dislodement

  Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen

  Through the duration of the 1-week post-stent removal study period

• Safety - Freedom From Major Complications: Tissue Injury

  Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.

  Through the duration of the 1-week post-stent removal study period

• Safety - Freedom From Major Complications: SAE's

  Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.

  Through the duration of the 1-week post-stent removal study period

Secondary Outcomes (4)

• Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days

  Up to 60 days

• Effectiveness: Stent Removability at 30 Days and/or 60 Days

  Up to 60 days

• Effectiveness: Technical Success

  Up to 60 days

• Clinical Success

  Up to 60 days

Study Arms (1)

AXIOS Stent and Delivery System

EXPERIMENTAL

Device: AXIOS Stent & Delivery System

Interventions

AXIOS Stent & Delivery System DEVICE

The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States. Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates. Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.

AXIOS Stent and Delivery System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (patients must meet all criteria)
• Age between 18 and 75 years old, male or female.
• Eligible for endoscopic intervention.
• Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
• Symptomatic pancreatic pseudocyst having the following characteristics:
• Greater than or equal to 6 cm in size (based upon the maximum crosssectional area in the CT scan),
• Adherent to bowel wall, and
• ≥70% fluid content
• Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
• Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

You may not qualify if:

• (patients meeting any of the below criteria will be excluded from study)
• \<18 or \>75 years of age
• Pancreatic pseudocysts having the following characteristics:
• Require nasocystic drainage,
• \< 69% 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
• Abnormal coagulation:
• INR \> 1.5 and not correctable
• presence of a bleeding disorder
• platelets \< 50,000/mm3

Sponsors & Collaborators

• Xlumena, Inc.: lead

Study Sites (7)

California Pacific Medical Center (CPMC)

San Francisco, California, 94115, United States

Location

Unversity of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

University of Chicago Medical Center (UCMC)

Chicago, Illinois, 60637, United States

Location

Cornell University

New York, New York, 10021, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Hospital Costa del Sol

Marbella, 951976669, Spain

Location

Related Publications (1)

• Shah RJ, Shah JN, Waxman I, Kowalski TE, Sanchez-Yague A, Nieto J, Brauer BC, Gaidhane M, Kahaleh M. Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents. Clin Gastroenterol Hepatol. 2015 Apr;13(4):747-52. doi: 10.1016/j.cgh.2014.09.047. Epub 2014 Oct 5.

  PMID: 25290534 DERIVED

Related Links

• click here for more information about the Sponsor

MeSH Terms

Conditions

Pancreatic Pseudocyst

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Lina Ginnetti
• Organization: Boston Scientific Corp.

Lina.Ginnetti@bsci.com

508-683-4512

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 18, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2013
• Last Updated: September 21, 2015
• Results First Posted: November 19, 2014

Record last verified: 2015-09

Locations

ES (1); US (6)