Pancreatic Pseudocyst(s) Clinical Trial
Official title:
A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | April 2013 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - (patients must meet all criteria) 1. Age between 18 and 75 years old, male or female. 2. Eligible for endoscopic intervention. 3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage 4. 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 5. 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. 6. 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) 1. <18 or >75 years of age 2. Pancreatic pseudocysts having the following characteristics: - Require nasocystic drainage, - < 69% fluid content 3. The fluid collection to be drained is an immature pseudocyst 4. The fluid collection to be drained is a cystic neoplasm 5. The fluid collection to be drained is a pseudoaneurysm 6. The fluid collection to be drained is a duplication cyst 7. The fluid collection to be drained is a non-inflammatory fluid collection 8. There is more than one pseudocyst requiring drainage 9. Abnormal coagulation: - INR > 1.5 and not correctable - presence of a bleeding disorder - platelets < 50,000/mm3 10. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis). 11. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound) 12. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient. 13. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study. 14. 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Costa del Sol | Marbella | |
| United States | Unversity of Colorado Denver | Aurora | Colorado |
| United States | University of Chicago Medical Center (UCMC) | Chicago | Illinois |
| United States | Borland-Groover Clinic | Jacksonville | Florida |
| United States | Cornell University | New York | New York |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | California Pacific Medical Center (CPMC) | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Xlumena, Inc. |
United States, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| 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 | Through the duration of the 1-week post-stent removal study period | Yes |
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| 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. | Through the duration of the 1-week post-stent removal study period | Yes |
| 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. | Through the duration of the 1-week post-stent removal study period | Yes |
| Secondary | 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 | No |
| 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. | Up to 60 days | No |
| 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. | Up to 60 days | No |
| 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. | Up to 60 days | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02146352 -
AXIOS Stent With Electrocautery Enhanced Delivery System
|
N/A |