Pancreatic Pseudocyst and Walled-off NecrosisNCT03808272
AXIOS CHINA (E7148)
A study testing HOT AXIOS Stent and Electrocautery- Enhanced Delivery System in people with Pancreatic Pseudocyst and Walled-off Necrosis, run by Boston Scientific Corporation at 1 site in China.
Trial summary
To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off necrosis in Chinese population, to support the regulatory approval by CFDA Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Pseudocyst and Walled-off Necrosis
- What is being tested?
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2019to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age between 18 and 75 years old(including 18 and 75 years old)
- Eligible for endoscopic intervention
- Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
- Diagnostic as symptomatic pancreatic pseudocysts ≥ 6cm in maximum diameter and walled-off necrosis ≥ 6cm in maximum diameter with ≥ 70% fluid content that are adherent to the gastric or bowel wall
- 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.
Who cannot join
- <18 or >75 years of age
- pseudocysts or walled-off necrosis which require nasocystic drainage,or<6cm in maximum diameter, or walled-off necrosis < 70% fluid content
- 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
Show all 14Show fewer
- 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
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
About this study
Official title: A Prospective, Multi-center, Single-arm Study to Evaluate the Safety and Efficacy of AXIOS Stent and Electrocautery-enhanced Delivery System in Chinese Patients With Pancreatic Pseudocyst and Walled-off Necrosis(WON)
To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off necrosis in Chinese population, to support the regulatory approval by CFDA
- Being tested
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
- Medical subject headings
- Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOT AXIOS Stent and Electrocautery- Enhanced Delivery SystemDevice
The HOT AXIOS Stent and Electrocautery- Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with ≥ 70% fluid content.
| Study group | Role | What they receive |
|---|---|---|
| HOT AXIOS Stent and Electrocautery- Enhanced Delivery System | Experimental | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System Receives: Device: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
defined as: placement of the AXIOS stent using the Electrocautery Enhanced AXIOS delivery system and removal of the AXIOS stent using a standard method: such as endoscopic snare or forceps.
Measured: 28± 7 days post stent placement
Clinical success rate
defined as: at least a 50% decrease in pseudocyst's maximum diameter, based on radiographic analysis
Measured: 28± 7 days post stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start17 Apr 2019
- Primary completion24 Dec 2020
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Pseudocyst and Walled-off NecrosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shutian Zhang, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808272
- Sponsor's protocol ID
- E7148
- Status last verified
- Nov 2023
- First submitted
- 16 Jan 2019
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single-arm Study to Evaluate the Safety and Efficacy of AXIOS Stent and Electrocautery-enhanced Delivery System in Chinese Patients With Pancreatic Pseudocyst and Walled-off Necrosis(WON)
- ClinicalTrials.gov ID
- NCT03808272
- Acronym / sponsor ID
- E7148
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off necrosis in Chinese population, to support the regulatory approval by CFDA
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOT AXIOS Stent and Electrocautery- Enhanced Delivery System | Experimental | Device: HOT AXIOS Stent and Electrocautery- Enhanced Delivery SystemHOT AXIOS Stent and Electrocautery- Enhanced Delivery System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 75 years old(including 18 and 75 years old)
- Eligible for endoscopic intervention
- Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
- Diagnostic as symptomatic pancreatic pseudocysts ≥ 6cm in maximum diameter and walled-off necrosis ≥ 6cm in maximum diameter with ≥ 70% fluid content that are adherent to the gastric or bowel wall
- Patient understands the study requirements and the treatment procedures and provides written Informed Consent.
Key exclusion criteria (14 listed)
- <18 or >75 years of age
- pseudocysts or walled-off necrosis which require nasocystic drainage,or<6cm in maximum diameter, or walled-off necrosis < 70% fluid content
- 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
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 |
|---|---|---|
| HOT AXIOS Stent and Electrocautery- Enhanced Delivery SystemThe HOT AXIOS Stent and Electrocautery- Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with ≥ 70% fluid content. | Device | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System |
Primary outcome
Technical success rate
Time frame: 28± 7 days post stent placement
defined as: placement of the AXIOS stent using the Electrocautery Enhanced AXIOS delivery system and removal of the AXIOS stent using a standard method: such as endoscopic snare or forceps.
Clinical success rate
Time frame: 28± 7 days post stent placement
defined as: at least a 50% decrease in pseudocyst's maximum diameter, based on radiographic analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Pseudocyst and Walled-off Necrosis
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
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.
Shutian Zhang principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOT AXIOS Stent and Electrocautery- Enhanced Delivery System in people with Pancreatic Pseudocyst and Walled-off Necrosis, run by Boston Scientific Corporation at 1 site in China.
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 6 inclusion and 14 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Technical success rate (time frame: 28± 7 days post stent placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2023.