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2011-08
2012-06
2013-04
30
NCT01419769
Xlumena, Inc.
Xlumena, Inc.
INTERVENTIONAL
AXIOS Stent & Delivery System Study
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: 1. Access site-related bleeding requiring transfusion; 2. Access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization; 3. Surgery for access-site related perforation; 4. Stent migration/dislodgement into the pseudocyst or enteral lumen; 5. Tissue injury, defined as ulceration to the submucosa at site of stent implant as observed to persist through 1-week post-stent removal. 6. Serious adverse event classified as implant-associated or implant/endoscopic procedure-associated; Effectiveness: 1. Stent lumen patency at 30 days and/or 60 days 2. Stent removability at 30 days and/ or 60 days. 3. 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. 4. 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-08-15 | 2014-11-12 | 2015-09-02 |
2011-08-17 | 2014-11-12 | 2015-09-21 |
2011-08-18 | 2014-11-19 | 2015-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: AXIOS Stent and Delivery System | DEVICE: AXIOS Stent & Delivery System
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
