Pancreatic Pseudocyst(s)NCT01419769
AXIOS Stent & Delivery System Study
A study testing AXIOS Stent & Delivery System in people with Pancreatic Pseudocyst(s), run by Xlumena, Inc. at 7 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Pseudocyst(s)
- What is being tested?
- AXIOS Stent & Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Aug 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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),
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- 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.
Who cannot join
- (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
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- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Unversity of Colorado Denver
Aurora, Colorado, 80045
University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637
Borland-Groover Clinic
Jacksonville, Florida, 32256
Cornell University
New York, New York, 10021
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
California Pacific Medical Center (CPMC)
San Francisco, California, 94115
About this study
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.
Read the detailed description
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.
- Conditions
- Pancreatic Pseudocyst(s)
- Being tested
- AXIOS Stent & Delivery System
- Keywords
- symptomatic pancreatic pseudocyst, pancreatic pseudocyst, transluminal drainage, minimally invasive, Nitinol stent, transmural endoscopic drainage, catheter based
- Medical subject headings
- Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXIOS Stent & Delivery SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AXIOS Stent and Delivery System | Experimental | Not described Receives: Device: AXIOS Stent & Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Freedom From Major Complications: Access Site-related Bleeding
Subjects are free of access site-related bleeding requiring transfusion
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Through the duration of the 1-week post-stent removal study period
Secondary outcomes (4)
Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days
Stent lumen patency at 30 days and/or 60 days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Pseudocyst(s)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xlumena, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419769
- Sponsor's protocol ID
- CD00744
- Status last verified
- Sep 2015
- First submitted
- 15 Aug 2011
- Last updated
- 21 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25290534
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System
- ClinicalTrials.gov ID
- NCT01419769
- Acronym / sponsor ID
- CD00744
- Conditions
- Pancreatic Pseudocyst(s)
- Keywords
- symptomatic pancreatic pseudocyst, pancreatic pseudocyst, transluminal drainage, minimally invasive, Nitinol stent, transmural endoscopic drainage, catheter based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Xlumena, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Posted 19 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AXIOS Stent and Delivery System | Experimental | Device: AXIOS Stent & Delivery System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- (patients must meet all criteria)
Key exclusion criteria (20 listed)
- (patients meeting any of the below criteria will be excluded from study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXIOS Stent & Delivery SystemThe 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. | Device | AXIOS Stent and Delivery System |
Primary outcome
Safety - Freedom From Major Complications: Access Site-related Bleeding
Time frame: Through the duration of the 1-week post-stent removal study period
Subjects are free of access site-related bleeding requiring transfusion
Safety - Freedom From Major Complications: Access Site-related Infection
Time frame: Through the duration of the 1-week post-stent removal study period
Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
Safety - Freedom From Major Complications: Perforation
Time frame: Through the duration of the 1-week post-stent removal study period
Subjects are free of surgery for access-site related perforation
Safety - Freedom From Major Complications: Stent Migration/Dislodement
Time frame: Through the duration of the 1-week post-stent removal study period
Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen
Safety - Freedom From Major Complications: Tissue Injury
Time frame: Through the duration of the 1-week post-stent removal study period
Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.
Safety - Freedom From Major Complications: SAE's
Time frame: Through the duration of the 1-week post-stent removal study period
Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.
4 secondary outcomes
Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days
Time frame: Up to 60 days
Effectiveness: Stent Removability at 30 Days and/or 60 Days
Time frame: Up to 60 days
Effectiveness: Technical Success
Time frame: Up to 60 days
Clinical Success
Time frame: Up to 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25290534Shah 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.
- click here for more information about the SponsorLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AXIOS Stent & Delivery System in people with Pancreatic Pseudocyst(s), run by Xlumena, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Freedom From Major Complications: Access Site-related Bleeding (time frame: Through the duration of the 1-week post-stent removal study period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01419769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2015.