AXIOS Stent & Delivery System Study

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVE: To demonstrate the safety and effectiveness of the Xlumena AXIOS Stent and Delivery System for endoscopic drainage of pancreatic pseudocysts in patients with symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm (≥6cm) in diameter, have ≥ 70% fluid contents and are adherent to the bowel wall. STUDY DESIGN: Prospective, multi-center, non-blinded, single-arm (nonrandomized) study KEY ENDPOINTS: Safety: The safety endpoint is freedom from major complications through the duration of the 1-week post-stent removal study period, defined as: Access site-related bleeding requiring transfusion; Access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization; Surgery for access-site related perforation; Stent migration/dislodgement into the pseudocyst or enteral lumen; Tissue injury, defined as ulceration to the submucosa at site of stent implant as observed to persist through 1-week post-stent removal. Serious adverse event classified as implant-associated or implant/endoscopic procedure-associated; Effectiveness: Stent lumen patency at 30 days and/or 60 days Stent removability at 30 days and/ or 60 days. Technical success, defined as: placement of the AXIOS stent using the AXIOS delivery system and removal of the AXIOS stent using a standard endoscopic snare. Clinical success, defined as: at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days. PATIENT POPULATION: Patients between 18 and 75 years of age, suitable for transluminal drainage of symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm in diameter and adherent to the bowel wall are candidates for study treatment. FOLLOW-UP SCHEDULE: Clinical follow-up evaluations of study endpoints will be conducted at 30 days and/or 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal. PLANNED NUMBER OF PATIENTS, SITES & REGIONS: The target enrollment for the study is 24 subjects. Study will be conducted at up to 10 investigational sites in the United States, Japan and/or the European Community. A majority of the patients will be enrolled in the United States.

Official Title
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A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System

Conditions
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Pancreatic Pseudocyst(s)

Intervention / Treatment
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* Device: AXIOS Stent & Delivery System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (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. Exclusion Criteria: (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 Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis). Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound) Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study. Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXIOS Stent and Delivery System<br> | Device: AXIOS Stent & Delivery System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days | Stent lumen patency at 30 days and/or 60 days. | Up to 60 days | 
| Effectiveness: Stent Removability at 30 Days and/or 60 Days | AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit. | Up to 60 days | 
| Effectiveness: Technical Success | Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare. | Up to 60 days | 
| Clinical Success | Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days. | Up to 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitinol stent, symptomatic pancreatic pseudocyst, pancreatic pseudocyst, transluminal drainage, minimally invasive, transmural endoscopic drainage, catheter based