Biliary Tract DiseasesSpyChinaNCT02287194
SpyGlass Direct Visualization System Clinical Registry in China
An observational study of Biliary Tract Diseases, run by Boston Scientific Corporation at 1 site in China.
Trial summary
To document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System in China when used per standard of practice. Prospective, Post market, Multi-center, Non-randomized Study Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Biliary Tract Diseases
- What is being tested?
- SpyGlass
- Type of treatment
- Medical device
- How many people
- 197 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2014to 31 Dec 2017
- How long will I take part?
- 6 Months
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients seen at an investigational site during the enrollment period * Presenting with an indication for cholangioscopy, or * Presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure.
Who may be able to join
- Age above 18 and not above 85.
- Willing and able to provide written informed consent to participate in the study.
- Willing and able to comply with the study procedures.
- Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy.
Who cannot join
- Endoscopic techniques are contraindicated.
- ERCP is contraindicated
- A medical condition that warrants the use of the device outside of the indication for use.
- Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System Throughout China
To document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System in China when used per standard of practice.
Prospective, Post market, Multi-center, Non-randomized Study
Read the detailed description
Patients who presenting with an indication for cholangioscopy or presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure will join this study, totally 500 patients across 16 sites throughout China will participate in study. After SpyGlass operation, all patients will be followed for 72 hours to observe adverse events, and patients with indeterminate stricture or undefined filling defect indication with tissue sampling not yielding histopathology positive for malignancy and unresolved device and/or procedure related SAE at 72 Hours will continue to be followed up until 6 months. Finally, procedure success rate will be analyzed as primary endpoint, and SAEs and impact of patients management will be analyzed as secondary endpoint.
- Conditions
- Biliary Tract Diseases
- Being tested
- SpyGlass
- Medical subject headings
- Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpyGlassDevice
The SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.
| Study group | Role | What they receive |
|---|---|---|
| SpyGlass Direct Visualization System | Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of biliary tract diseases. Receives: Device: SpyGlass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rate
- For indeterminate strictures or undefined filling defects cases procedural success is defined as 1) ability to visualize stricture or defect, and 2) ability to provide visual impression of malignancy, and 3) when applicable, ability to obtain SpyBite biopsy adequate for histology
- For biliary stone cases procedural success is defined as 1) ability to visualize the stone(s), and 2) ability to successfully initiate stone fragmentation, and 3) ability to achieve stone clearance in one or more SpyGlass procedures.
- For other indications procedural success is defined as ability to establish diagnosis and /or complete therapy in the following categories: 1) pre-operative assessment of extent of peri-ampullary and biliary tumors, 2) selective guidewire placement, 3) assessment of unexplained hemobilia, 4) assessment of portal biliopathy, 5) assessment of intraductal biliary ablation therapy, 6) extraction of migrated stents, or 7) other.
Measured: 72 hours
Secondary outcomes (1)
Safety Endpoints
Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit.
Measured: Post Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study start28 Nov 2014
- Primary completion30 Apr 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract 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
- 197 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaoshen Li, Prof., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287194
- Sponsor's protocol ID
- E7101
- Acronym
- SpyChina
- Status last verified
- Sep 2017
- First submitted
- 20 Aug 2014
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chen YK. Preclinical characterization of the Spyglass peroral cholangiopancreatoscopy system for direct access, visualization, and biopsy. Gastrointest Endosc. 2007 Feb;65(2):303-11. doi: 10.1016/j.gie.2006.07.048.
PubMed 17258991
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System Throughout China
- ClinicalTrials.gov ID
- NCT02287194
- Acronym / sponsor ID
- SpyChina / E7101
- Conditions
- Biliary Tract Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2014 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 10 Nov 2014 (estimated)
- 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 indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System in China when used per standard of practice.
Prospective, Post market, Multi-center, Non-randomized Study
Detailed description
Patients who presenting with an indication for cholangioscopy or presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure will join this study, totally 500 patients across 16 sites throughout China will participate in study. After SpyGlass operation, all patients will be followed for 72 hours to observe adverse events, and patients with indeterminate stricture or undefined filling defect indication with tissue sampling not yielding histopathology positive for malignancy and unresolved device and/or procedure related SAE at 72 Hours will continue to be followed up until 6 months. Finally, procedure success rate will be analyzed as primary endpoint, and SAEs and impact of patients management will be analyzed as secondary endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpyGlass Direct Visualization System | – | Device: SpyGlassAny patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of biliary tract diseases. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients seen at an investigational site during the enrollment period * Presenting with an indication for cholangioscopy, or * Presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure.
Key inclusion criteria (4 listed)
- Age above 18 and not above 85.
- Willing and able to provide written informed consent to participate in the study.
- Willing and able to comply with the study procedures.
- Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy.
Key exclusion criteria (4 listed)
- Endoscopic techniques are contraindicated.
- ERCP is contraindicated
- A medical condition that warrants the use of the device outside of the indication for use.
- Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
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 |
|---|---|---|
| SpyGlassThe SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices. | Device | SpyGlass Direct Visualization System |
Primary outcome
Procedural success rate
Time frame: 72 hours
1. For indeterminate strictures or undefined filling defects cases procedural success is defined as 1) ability to visualize stricture or defect, and 2) ability to provide visual impression of malignancy, and 3) when applicable, ability to obtain SpyBite biopsy adequate for histology 2. For biliary stone cases procedural success is defined as 1) ability to visualize the stone(s), and 2) ability to successfully initiate stone fragmentation, and 3) ability to achieve stone clearance in one or more SpyGlass procedures. 3. For other indications procedural success is defined as ability to establish diagnosis and /or complete therapy in the following categories: 1) pre-operative assessment of extent of peri-ampullary and biliary tumors, 2) selective guidewire placement, 3) assessment of unexplained hemobilia, 4) assessment of portal biliopathy, 5) assessment of intraductal biliary ablation therapy, 6) extraction of migrated stents, or 7) other.
1 secondary outcome
Safety Endpoints
Time frame: Post 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 31 Jul 2018.
- Background: PubMed 17258991Chen YK. Preclinical characterization of the Spyglass peroral cholangiopancreatoscopy system for direct access, visualization, and biopsy. Gastrointest Endosc. 2007 Feb;65(2):303-11. doi: 10.1016/j.gie.2006.07.048.
- Individual participant dataSharing planned: No
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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.
Zhaoshen Li, Prof. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Diseases, 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 4 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 31 Jul 2018. 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?
Procedural success rate (time frame: 72 hours). 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 NCT02287194, 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 31 Jul 2018.