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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.
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:
Effectiveness:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXIOS Stent and Delivery System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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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:
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:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center (CPMC) | San Francisco | California | 94115 | United States | ||
| Unversity of Colorado Denver |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25290534 | Derived | 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. |
| Label | URL |
|---|---|
| click here for more information about the Sponsor | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AXIOS Stent and Delivery System | AXIOS Stent & Delivery System: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AXIOS Stent and Delivery System | AXIOS Stent & Delivery System: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety - Freedom From Major Complications: Access Site-related Bleeding | Subjects are free of access site-related bleeding requiring transfusion | Intent-to-Treat population | Posted | Number | percentage of patients | Through the duration of the 1-week post-stent removal study period |
|
From index procedure up to 6 months post-stent removal
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AXIOS Stent and Delivery System | AXIOS Stent & Delivery System: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lina Ginnetti | Boston Scientific Corp. | 508-683-4512 | Lina.Ginnetti@bsci.com |
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| ID | Term |
|---|---|
| D010192 | Pancreatic Pseudocyst |
| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
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|
| 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 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States |
| University of Chicago Medical Center (UCMC) | Chicago | Illinois | 60637 | United States |
| Cornell University | New York | New York | 10021 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Hospital Costa del Sol | Marbella | 951976669 | Spain |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds |
|
|
|
| Secondary | Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days | Stent lumen patency at 30 days and/or 60 days. | Patients treated per protocol with successful stent placement. | Posted | Number | percentage of patients | Up to 60 days |
|
|
|
| Secondary | 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. | Patients who had AXIOS stent successfully placed during index procedure. | Posted | Number | percentage of patients | Up to 60 days |
|
|
|
| Secondary | Effectiveness: Technical Success | Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare. | Intent-to-Treat population | Posted | Number | participants | Up to 60 days |
|
|
|
| Secondary | 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. | Patients treated per protocol. | Posted | Number | percentage of patients | Up to 60 days |
|
|
|
| Primary | 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 | Per protocol population | Posted | Number | percentage of patients | Through the duration of the 1-week post-stent removal study period |
|
|
|
| Primary | Safety - Freedom From Major Complications: Perforation | Subjects are free of surgery for access-site related perforation | Intent-to-Treat population | Posted | Number | percentage of patients | Through the duration of the 1-week post-stent removal study period |
|
|
|
| Primary | Safety - Freedom From Major Complications: Stent Migration/Dislodement | Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen | Per protocol population of subjects with stent successfully placed | Posted | Number | percentage of patients | Through the duration of the 1-week post-stent removal study period |
|
|
|
| Primary | 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. | Per protocol population | Posted | Number | percentage of patients | Through the duration of the 1-week post-stent removal study period |
|
|
|
| Primary | Safety - Freedom From Major Complications: SAE's | Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated. | Intent-to-Treat population | Posted | Number | percentage of patients | Through the duration of the 1-week post-stent removal study period |
|
|
|
| 16 |
| 33 |
| 15 |
| 33 |
| Abdominal pain and nausea after eating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain and vomiting after eating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain, nausea, and vomiting after eating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain and syncope, GI bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea and vomiting only after eating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Chest pain and pressure, shortness of breath, heart palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| GI Bleed | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache and lightheadedness/ dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Intraperitoneal air | Gastrointestinal disorders | Non-systematic Assessment |
|
| Left shoulder/ back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Respiratory failure | Cardiac disorders | Non-systematic Assessment |
|
| Severe dehydration | General disorders | Non-systematic Assessment |
|
| Mucus overgrowth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea after eating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| Vomiting after eating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lightheadedness/ dizziness | General disorders | Non-systematic Assessment |
|
| New pancreatic pseudocyst | Gastrointestinal disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Black stool | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bleeding | General disorders | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flank pain | General disorders | Non-systematic Assessment |
|
| J-tube clogged | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Pancreatic duct obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Peripancreatic inflammation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
PI must wait 9 months after close of study for Sponsor to present collaborative publication. If Sponsor does not publish within 9 months after close of study, PI is free to publish institution's results at that time.
Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 6 months from the date the PI receives the objection. The Sponsor cannot require changes to the communication and cannot extend the embargo.
| D004066 |
| Digestive System Diseases |