Pancreatic Pseudocyst InfectionNCT03797209
Hot AXIOS System Japan Post Market Survey
An observational study of Pancreatic Pseudocyst Infection and Pancreatic Pseudocyst, run by Boston Scientific Japan K.K. at 40 sites in Japan.
Trial summary
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst, Walled Off Necrosis Infection
- What is being tested?
- EUS-guided fistulization AXIOS
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 40 sitesJapan
- Study dates
- 15 Jan 2019to 30 Oct 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient who received implant procedure using study device at Japanese site.
Who may be able to join
- Patient who received implant procedure using study device at Japanese site.
Who cannot join
- NA
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Japan40 sites
Juntendo University Hospital
Bunkyo-Ku, Tokyo, 113-8431
Chiba University Hospital
Chiba, Chiba, 260-8677
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Saitama Medical Universtity International Medical Center
Hidaka-Shi, Saitama, 350-1298
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520
Shonan Kamakura General Hospital
Kamakura-Shi, Kanagawa, 247-8533
Kameda Medical Center
Kamogawa-Shi, Chiba, 296-8602
National Cancer Center Hospital East
Kashiwa-Shi, Chiba, 277-8577
Saitama Medical Center
Kawagoe-Shi, Saitama, 350-8550
Kitasato University Medical Center
Kitamoto-Shi, Saitama, 364-8501
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Toho University Ohashi Medical Center
Meguro-Ku, Tokyo, 153-8515
The Jikei University Hospital
Minato-Ku, Tokyo, 105-8471
Kyorin University Hospital
Mitaka-Shi, Tokyo, 181-8611
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692
Aichi Medical University Hospital
Nagakute-Shi, Aichi-ken, 480-1195
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
Hyogo College of Medicine Hospital
Nishinomiya-Shi, Hyōgo, 663-8501
Kawasaki Medical School General Medical Center
Okayama, Okayama-ken, 700-8505
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Osaka City University Hospital
Osaka, Osaka, 545-8586
Kindai University Hospital
Osakasayama-Shi, Osaka, 589-8511
Kitasato University Hospital
Sagamihara-Shi, Kanagawa, 252-0375
Teine Keijinkai Hospital
Sapporo, Hokkaido, 006-8555
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Sendai Open Hospital
Sendai, Miyagi, 983-0824
Jichi Medical University Hospital
Shimotsuke-Shi, Tochigi, 329-0498
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666
Osaka Medical College Hospital
Takatsuki-Shi, Osaka, 569-8686
Tokyo Medical University Hospital
Tokyo, Shinjuku-Ku, 160-0023
Mie University Hospital
Tsu, Mie-ken, 514-8507
Saiseikai Utsunomiya Hospital
Utsunomiya, Tochigi, 321-0974
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Tokyo Women's Medical University Yachiyo Medical Center
Yachiyo-Shi, Chiba, 276-8524
Yokohama Rosai Hospital
Yokohama, Kanagawa, 222-0036
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
About this study
Official title: A Post Market Survey to Detect Information of Adverse Events and Device Malfunctions of AXIOS Stent and Electrocautery Enhanced Delivery System Under Real World Medical Condition in Japan
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
- Conditions
- Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst, Walled Off Necrosis Infection, Walled Off Necrosis
- Being tested
- EUS-guided fistulization AXIOS
- Keywords
- PPC, WON
- Medical subject headings
- Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided fistulization AXIOSDevice
By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.
| Study group | Role | What they receive |
|---|---|---|
| AXIOS Patient | Not described Receives: Device: EUS-guided fistulization AXIOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Adverse Events and Device Malfunction)
Measured: From implant procedure to 7 days after removal
Placement success
AXIOS stent is placed in an appropriate position using the delivery system.
Measured: During implant procedure
Stent retention
AXIOS stent stays at the position where it was implanted during the implant procedure.
Measured: From implant procedure to removal (a maximum of 60 days)
Stent lumen patency
The lumen of AXIOS stent is patent, and it can be used for drainage etc.
Measured: From implant procedure to removal (a maximum of 60 days)
Decreased cyst size
Measured: From implant procedure to final observation (a maximum of 60 days)
Removal success
AXIOS stent can be removed using standard endoscopic snares or forceps.
Measured: Removal procedure (a maximum of 60 days after implant procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start15 Jan 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Pseudocyst InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Japan K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797209
- Sponsor's protocol ID
- E7121
- Status last verified
- Mar 2022
- First submitted
- 25 Sep 2018
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Survey to Detect Information of Adverse Events and Device Malfunctions of AXIOS Stent and Electrocautery Enhanced Delivery System Under Real World Medical Condition in Japan
- ClinicalTrials.gov ID
- NCT03797209
- Acronym / sponsor ID
- E7121
- Conditions
- Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst, Walled Off Necrosis Infection, Walled Off Necrosis
- Keywords
- PPC, WON
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Boston Scientific Japan K.K.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 9 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 detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AXIOS Patient | – | Device: EUS-guided fistulization AXIOS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who received implant procedure using study device at Japanese site.
Key inclusion criteria (1 listed)
- Patient who received implant procedure using study device at Japanese site.
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| EUS-guided fistulization AXIOSBy using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage. | Device | AXIOS Patient |
Primary outcome
Safety (Adverse Events and Device Malfunction)
Time frame: From implant procedure to 7 days after removal
Placement success
Time frame: During implant procedure
AXIOS stent is placed in an appropriate position using the delivery system.
Stent retention
Time frame: From implant procedure to removal (a maximum of 60 days)
AXIOS stent stays at the position where it was implanted during the implant procedure.
Stent lumen patency
Time frame: From implant procedure to removal (a maximum of 60 days)
The lumen of AXIOS stent is patent, and it can be used for drainage etc.
Decreased cyst size
Time frame: From implant procedure to final observation (a maximum of 60 days)
Removal success
Time frame: Removal procedure (a maximum of 60 days after implant procedure)
AXIOS stent can be removed using standard endoscopic snares or forceps.
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 18 Mar 2022.
- Individual participant dataSharing planned: No
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.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Pseudocyst Infection and Pancreatic Pseudocyst, run by Boston Scientific Japan K.K. at 40 sites in Japan.
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 1 inclusion and 1 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Japan. 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?
Safety (Adverse Events and Device Malfunction) (time frame: From implant procedure to 7 days after removal). 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?
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 18 Mar 2022.