Pancreatic DiseasesNCT04580940
SpyGlass™ Discover Percutaneous
An observational study of Pancreatic Diseases and Bile Duct Obstruction, run by Boston Scientific Corporation at 7 sites in 7 countries.
Trial summary
To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Diseases, Bile Duct Obstruction, Bile Duct Diseases
- What is being tested?
- SpyGlass™ Discover Digital System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 27 Jul 2021to 14 Jan 2023
- How long will I take part?
- 1 Month
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with complex pancreaticobiliary disease
Who may be able to join
- Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice
- Written informed consent from patient or legally authorized representative of the patient
Who cannot join
- Contraindication for cholangiopancreatoscopy
- Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access
- <18 years of age
- Potentially vulnerable subjects, including, but not limited to pregnant women
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G2N2
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
About this study
Official title: Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease
To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series
Read the detailed description
This case series aims to illustrate the clinical utility of percutaneous transhepatic cholangiopancreatoscopy using a thin, disposable, flexible endoscope performed by gastroenterological endoscopists and/or interventional radiologists in procedures including but not limited to:
- PTCS for tissue diagnosis in cases of surgically or pathologically-altered anatomy,
- PTCS for stone removal after surgically or pathologically-altered anatomy,
- Percutaneous rendezvous to aid ERCP after failed endoscopic cannulation,
- Percutaneous delivery of palliative intraluminal brachytherapy,
- Intra-procedural percutaneous salvage procedures when an initial route of access fails
- Being tested
- SpyGlass™ Discover Digital System
- Keywords
- Percutaneous transhepatic cholangiopancreatoscopy, spyglass discover, pancreaticobiliary disease
- Medical subject headings
- Pancreatic Diseases, Cholestasis, Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpyGlass™ Discover Digital SystemDevice
Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with complex pancreaticobiliary disease | All subjects will undergo the percutaneous transhepatic cholangiopancreatoscopy with the SpyGlass Discover System. Receives: Device: SpyGlass™ Discover Digital System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving clinical intent of procedure as indicated
Physicians will report achieving clinical success by recording the completed procedures compared to procedures planned by 30 days (+/- 3 days) after index PTCS.
Measured: 1 month
Secondary outcomes (5)
Number of Adverse Events
Serious adverse events related to the study device, accessory devices used through the working channel of the SpyGlass™ Discover Digital Catheter or the cholangiopancreatoscopy portion of the PTCS procedure(s).
Measured: 1 month
Technical success
Rate at which SpyGlass™ Discover digital catheter can be advanced to the target lesion or stone(s) and visualize the target
Measured: During index procedure
Procedural Time
Time elapsed between first insertion to last removal of the SpyGlass™ Discover digital catheter
Measured: During index procedure
Number of PTCS procedures
Number of PTCS procedures required to achieve clinical success until the end of follow-up
Measured: 1 month
Endoscopist rating
Endoscopist rating of the following attributes when using SpyGlass™ Discover Digital Catheter compared to marketed reusable scopes Ability to complete the procedure Ability to retroflex Ability to selectively advance into targeted ducts Ability to obtain targeted biopsies Ability to grasp stones Ability to guide lithotripsy Ability to suction Ability to irrigate Ability to advance accessories through scope channel Image quality
Measured: During index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start27 Jul 2021
- Primary completion14 Dec 2022
- Study completion14 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivo Boskoski, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSTorsten Beyna, MD, PhD, Principal investigator, Evangelisches Krakenhaus DüsseldorfMehran Fotoohi, MD, PhD, Principal investigator, Virginia MasonArnaud Lemmers, MD, PhD, Principal investigator, Erasme University HospitalJames Lau, MD, PhD, Principal investigator, Prince of Wales Hospital, Shatin, Hong KongEran Shlomovitz, MD, PhD, Principal investigator, Toronto General Hospital, University Health NetworkMohan Ramchandani, MD, PhD, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580940
- Sponsor's protocol ID
- E7160
- Status last verified
- Nov 2023
- First submitted
- 23 Sep 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Boskoski I, Beyna T, Lau JY, Lemmers A, Fotoohi M, Ramchandani M, Pontecorvi V, Peetermans J, Shlomovitz E. Efficacy and safety of a single-use cholangioscope for percutaneous transhepatic cholangioscopy. Endosc Int Open. 2024 Aug 23;12(8):E981-E988. doi: 10.1055/a-2366-2265. eCollection 2024 Aug.
PubMed 39184059Aihara H, Othman MO, Jawaid SA, Gorgun E, Sharma NR, Siddiqui UD, Peetermans JA, Rousseau MJ, Nishimura M. A multicenter, retrospective study of a through-the-needle injection-capable electrosurgical knife for endoscopic submucosal dissection. Gastrointest Endosc. 2024 Dec;100(6):1034-1042. doi: 10.1016/j.gie.2024.06.011. Epub 2024 Jun 13.
PubMed 38879045
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease
- ClinicalTrials.gov ID
- NCT04580940
- Acronym / sponsor ID
- E7160
- Keywords
- Percutaneous transhepatic cholangiopancreatoscopy, spyglass discover, pancreaticobiliary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Jan 2023 (actual)
- First posted
- 9 Oct 2020 (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 document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series
Detailed description
This case series aims to illustrate the clinical utility of percutaneous transhepatic cholangiopancreatoscopy using a thin, disposable, flexible endoscope performed by gastroenterological endoscopists and/or interventional radiologists in procedures including but not limited to:
- PTCS for tissue diagnosis in cases of surgically or pathologically-altered anatomy,
- PTCS for stone removal after surgically or pathologically-altered anatomy,
- Percutaneous rendezvous to aid ERCP after failed endoscopic cannulation,
- Percutaneous delivery of palliative intraluminal brachytherapy,
- Intra-procedural percutaneous salvage procedures when an initial route of access fails
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with complex pancreaticobiliary disease | – | Device: SpyGlass™ Discover Digital SystemAll subjects will undergo the percutaneous transhepatic cholangiopancreatoscopy with the SpyGlass Discover System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with complex pancreaticobiliary disease
Key inclusion criteria (2 listed)
- Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice
- Written informed consent from patient or legally authorized representative of the patient
Key exclusion criteria (4 listed)
- Contraindication for cholangiopancreatoscopy
- Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access
- <18 years of age
- Potentially vulnerable subjects, including, but not limited to pregnant women
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 |
|---|---|---|
| SpyGlass™ Discover Digital SystemObservational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure. | Device | Subjects with complex pancreaticobiliary disease |
Primary outcome
Achieving clinical intent of procedure as indicated
Time frame: 1 month
Physicians will report achieving clinical success by recording the completed procedures compared to procedures planned by 30 days (+/- 3 days) after index PTCS.
5 secondary outcomes
Number of Adverse Events
Time frame: 1 month
Technical success
Time frame: During index procedure
Procedural Time
Time frame: During index procedure
Number of PTCS procedures
Time frame: 1 month
Endoscopist rating
Time frame: During index procedure
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 29 Nov 2023.
- Derived from this study: PubMed 39184059Boskoski I, Beyna T, Lau JY, Lemmers A, Fotoohi M, Ramchandani M, Pontecorvi V, Peetermans J, Shlomovitz E. Efficacy and safety of a single-use cholangioscope for percutaneous transhepatic cholangioscopy. Endosc Int Open. 2024 Aug 23;12(8):E981-E988. doi: 10.1055/a-2366-2265. eCollection 2024 Aug.
- Derived from this study: PubMed 38879045Aihara H, Othman MO, Jawaid SA, Gorgun E, Sharma NR, Siddiqui UD, Peetermans JA, Rousseau MJ, Nishimura M. A multicenter, retrospective study of a through-the-needle injection-capable electrosurgical knife for endoscopic submucosal dissection. Gastrointest Endosc. 2024 Dec;100(6):1034-1042. doi: 10.1016/j.gie.2024.06.011. Epub 2024 Jun 13.
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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.
Ivo Boskoski, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Torsten Beyna, MD, PhD principal investigator
Evangelisches Krakenhaus Düsseldorf
Mehran Fotoohi, MD, PhD principal investigator
Virginia Mason
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Diseases and Bile Duct Obstruction, run by Boston Scientific Corporation at 7 sites in 7 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 2 inclusion and 4 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 29 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 7 sites in United States, Belgium, Canada, Germany, Hong Kong and 2 more countries. 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?
Achieving clinical intent of procedure as indicated (time frame: 1 month). 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 NCT04580940, which also lists 2 linked publications.
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 29 Nov 2023.