Pancreatic DiseasesNCT05822635
SpyGlass Surgical Study
An observational study of Pancreatic Diseases and Bile Duct Diseases, run by Boston Scientific Corporation at 5 sites in 4 countries.
Trial summary
To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Diseases, Bile Duct Diseases, Hepatic Disease
- What is being tested?
- SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Dec 2023to 3 Jan 2025
- 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
- Clinical indication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
- Written informed consent from patient or legally authorized representative of the patient
Who cannot join
- Contraindication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
- <18 years of age
- Potentially vulnerable subjects, including, but not limited to pregnant women
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
Indiana University Health
Indianapolis, Indiana, 46202
Mayo Clinic
Rochester, Minnesota, 55902
About this study
Official title: Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope
- To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
- To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study
Read the detailed description
This case series aims to document the clinical utility of intraoperative endoscopy using a thin, disposable, flexible cholangiopancreatoscope in procedures including but not limited to:
- Evaluation of biliary lesion(s) during surgical management of common bile duct (CBD) and intrahepatic duct (IHD) strictures, with or without biopsy
- Transcystic/transcholedochal clearance of biliary stone(s)/sludge/cast with or without mechanical, electrohydraulic or laser lithotripsy
- Treatment of hepatolithiasis
- Assessment of communication between the biliary tree and the cyst in the setting of ruptured hydatid parasitic cysts or abcesses
- Visualization of intraductal papillary mucinous neoplasm (IPMN) lesion(s) with or without biopsy
- Assessment of pancreatic duct (PD) strictures in chronic pancreatitis, with or without biopsy
- Conditions
- Pancreatic Diseases, Bile Duct Diseases, Hepatic Disease
- Being tested
- SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System
- Medical subject headings
- Pancreatic Diseases, Bile Duct Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpyGlass Discover Digital System or SpyGlass DS Direct Visualization SystemDevice
Observational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with complex pancreaticobiliary disease | All subjects will undergo the intraoperative endoscopy with either the SpyGlass Discover System or the SpyGlass DS Direct Visualization System. Receives: Device: SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Perform intraoperative endoscopy as intended using a thin, single-use, flexible cholangiopancreatoscope as desired, including but not limited to:
- Direct visualization of target lesion or stricture
- Obtaining biopsies
- Initiating and/or completing stone clearance
Measured: During study procedure
Secondary outcomes (4)
Number of adverse events
Serious adverse events related to the study device, accessory devices used throughout the working channel of the SpyGlass™ system, or the intraoperative endoscopy procedure
Measured: 1 month
Endoscopist rating of clinical impact of study procedure
Characterization and rating of the clinical benefit and impact of intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope to the surgical procedure on a 1 (highly dissatisfied) to 10 (highly satisfied) scale
Measured: During study procedure
Adequate diagnostic yield
Adequate diagnostic yield of tissue biopsy for histopathology assessment
Measured: 1 month
Endoscopist rating of device
Rating of the intraoperative performance of the SpyGlass™ system and accessories during intraoperative endoscopy procedure compared to marketed reusable endoscopes on a 1 (highly dissatisfied) to 10 (highly satisfied) scale:
- Image quality
- Ability to irrigate field of view through the irrigation channels
- Ability to aspirate through the working channel
- Ability to retroflex
- Ability to obtain targeted biopsies using biopsy forceps
- Ability to grasp stones using wire basket
- Ability to perform lithotripsy
- Ability to advance accessories through catheter
- Ability to selectively advance into targeted ducts
Measured: During study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Dec 2023
- Primary completion4 Dec 2024
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822635
- Sponsor's protocol ID
- E7161
- Status last verified
- Jan 2025
- First submitted
- 7 Apr 2023
- Last updated
- 8 Jan 2025
- Results posted
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope
- ClinicalTrials.gov ID
- NCT05822635
- Acronym / sponsor ID
- E7161
- Conditions
- Pancreatic Diseases, Bile Duct Diseases, Hepatic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 21 Apr 2023 (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 diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
- To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study
Detailed description
This case series aims to document the clinical utility of intraoperative endoscopy using a thin, disposable, flexible cholangiopancreatoscope in procedures including but not limited to:
- Evaluation of biliary lesion(s) during surgical management of common bile duct (CBD) and intrahepatic duct (IHD) strictures, with or without biopsy
- Transcystic/transcholedochal clearance of biliary stone(s)/sludge/cast with or without mechanical, electrohydraulic or laser lithotripsy
- Treatment of hepatolithiasis
- Assessment of communication between the biliary tree and the cyst in the setting of ruptured hydatid parasitic cysts or abcesses
- Visualization of intraductal papillary mucinous neoplasm (IPMN) lesion(s) with or without biopsy
- Assessment of pancreatic duct (PD) strictures in chronic pancreatitis, with or without biopsy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with complex pancreaticobiliary disease | – | Device: SpyGlass Discover Digital System or SpyGlass DS Direct Visualization SystemAll subjects will undergo the intraoperative endoscopy with either the SpyGlass Discover System or the SpyGlass DS Direct Visualization 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)
- Clinical indication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
- Written informed consent from patient or legally authorized representative of the patient
Key exclusion criteria (3 listed)
- Contraindication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
- <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 System or SpyGlass DS Direct Visualization SystemObservational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy procedure. | Device | Subjects with complex pancreaticobiliary disease |
Primary outcome
Technical success
Time frame: During study procedure
Perform intraoperative endoscopy as intended using a thin, single-use, flexible cholangiopancreatoscope as desired, including but not limited to: * Direct visualization of target lesion or stricture * Obtaining biopsies * Initiating and/or completing stone clearance
4 secondary outcomes
Number of adverse events
Time frame: 1 month
Endoscopist rating of clinical impact of study procedure
Time frame: During study procedure
Adequate diagnostic yield
Time frame: 1 month
Endoscopist rating of device
Time frame: During study 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 8 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Diseases
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
Recruiting
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Pancreatic Disease, Pancreatic Cancer
RecruitingPhase 2
Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors
VHL Pancreatic Neuroendocrine Tumors, Von Hippel-Lindau Disease
Not yet recruitingPhase 2
Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases
Liver Metastases, Non-Small Cell Lung Cancer
Recruiting
Pancreatic Cancer Screening in a Population at High Risk
Pancreatic Ductal Adenocarcinoma, Hereditary Diseases
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.
5 sites in 4 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 Diseases, run by Boston Scientific Corporation at 5 sites in 4 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 3 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 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, China, Hong Kong, India. 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 (time frame: During study procedure). 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 8 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.