Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of pancreatic pseudocysts.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | AXIOS Stent with Electrocautery Enhanced Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXIOS Stent with Electrocautery Enhanced Delivery System | Device | Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/Adverse Event Outcome Measure 1 | Freedom from access site-related bleeding requiring transfusion | Index procedure through 1-week post-stent removal |
| Safety/Adverse Event Outcome Measure 2 | Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization | Index procedure through 1-week post-stent removal |
| Safety/Adverse Event Outcome Measure 3 | Freedom from surgery for access-site related perforation | Index procedure through 1-week post-stent removal |
| Safety/Adverse Event Outcome 4 | Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen | Index procedure through 1-week post-stent removal |
| Safety/Adverse Event Outcome Measure 5 | Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal | Index procedure through 1-week post-stent removal |
| Safety/Adverse Event Outcome Measure 6 | Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure | Index procedure through 1-week post-stent removal |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Retention Outcome Measure | Stent Retention: The stent must remain in place for up to 60 days | 30 or 60 days post-procedure |
| Lumen Patency Outcome Measure | Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation. |
Not provided
Inclusion 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.
Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven A Edmundowicz, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| Baptist Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days. |
| 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/Adverse Event Outcome Measure 1 | Freedom from access site-related bleeding requiring transfusion | Entire patient cohort | Posted | Number | percentage of patients | Index procedure through 1-week post-stent removal |
|
|
Index procedure through 1-week post-stent removal
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lina Ginnetti | Boston Scientific Corp. | 508-683-4512 | Lina.Ginnetti@bsci.com |
Not provided
| ID | Term |
|---|---|
| D010192 | Pancreatic Pseudocyst |
| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 and/or 60 days post-procedure |
| Technical Success Outcome Measure 1 | Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System | Index Procedure |
| Clinical Success Outcome Measure | Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days | 30 or 60 days post-procedure |
| Technical Success Outcome Measure 2 | Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps | 30 or 60 Day Post-procedure |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Participants |
|
|
| Secondary | Stent Retention Outcome Measure | Stent Retention: The stent must remain in place for up to 60 days | Per Protocol Population | Posted | Number | percentage of patients | 30 or 60 days post-procedure |
|
|
|
| Secondary | Lumen Patency Outcome Measure | Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation. | Per Protocol | Posted | Number | percentage of patients | 30 and/or 60 days post-procedure |
|
|
|
| Secondary | Technical Success Outcome Measure 1 | Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System | Per Protocol | Posted | Number | percentage of patients | Index Procedure |
|
|
|
| Secondary | Clinical Success Outcome Measure | Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days | Entire patient cohort | Posted | Number | percentage of patients | 30 or 60 days post-procedure |
|
|
|
| Primary | Safety/Adverse Event Outcome Measure 2 | Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization | Entire patient cohort | Posted | Number | percentage of patients | Index procedure through 1-week post-stent removal |
|
|
|
| Primary | Safety/Adverse Event Outcome Measure 3 | Freedom from surgery for access-site related perforation | Entire patient cohort | Posted | Number | percentage of patients | Index procedure through 1-week post-stent removal |
|
|
|
| Primary | Safety/Adverse Event Outcome 4 | Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen | Patients for which AXIOS stent migration/dislodgement could be assessed | Posted | Number | percentage of patients | Index procedure through 1-week post-stent removal |
|
|
|
| Primary | Safety/Adverse Event Outcome Measure 5 | Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal | Patients for which AXIOS stent was removed and tissue at site of stent implant was observed at time of removal | Posted | Number | percentage of patients | Index procedure through 1-week post-stent removal |
|
|
|
| Primary | Safety/Adverse Event Outcome Measure 6 | Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure | Entire patient cohort | Posted | Number | percentage of patients | Index procedure through 1-week post-stent removal |
|
|
|
| Secondary | Technical Success Outcome Measure 2 | Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps | Per Protocol | Posted | Number | percentage of patients | 30 or 60 Day Post-procedure |
|
|
|
| 13 |
| 30 |
| 10 |
| 30 |
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Biliary Stricture | Hepatobiliary disorders | Non-systematic Assessment |
|
| Bleeding post-AXIOS stent removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Chest pain/shortness of breath | Cardiac disorders | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bleeding post-AXIOS stent removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Blood in urine | Renal and urinary disorders | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| Lightheadedness/ dizziness | General disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pancreatic duct leak | Endocrine disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Spontaneous stent migration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ulceration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Weight loss | Gastrointestinal 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 may publish institution's results at that time. Sponsor can review results prior to public release and embargo communications on trial results for a period that is more than 60 days but less than or equal to 6 months from the date the PI gets the objection. The Sponsor cannot require changes to the communication nor extend the embargo.
| D004066 |
| Digestive System Diseases |