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SpyGlass AMEA Registry

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ClinicalTrials.gov Identifier: NCT02281019
Recruitment Status : Unknown
Verified January 2016 by Boston Scientific Corporation.
Recruitment status was:  Active, not recruiting
First Posted : November 3, 2014
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.

Condition or disease Intervention/treatment
Biliary Stricture Biliary Obstruction Due to Common Bile Duct Stone Periampullary Tumor Hemobilia Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography) Device: SpyGlass DVS and SpyGlass DS

Study Type : Observational [Patient Registry]
Actual Enrollment : 526 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region
Study Start Date : November 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Group/Cohort Intervention/treatment
Indeterminate strictures or undefined filling defects Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.

Device: SpyGlass DVS and SpyGlass DS
Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed

Biliary stone cases Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.

Device: SpyGlass DVS and SpyGlass DS
Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed

Other indications Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.

Device: SpyGlass DVS and SpyGlass DS
Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed




Primary Outcome Measures :
  1. Procedural success for indeterminate strictures or undefined filling defects [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]
    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. Procedural success for biliary stone cases [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]
    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. Procedural success for other indications [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]
    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.


Secondary Outcome Measures :
  1. Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure [ Time Frame: Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit ]
    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.

  2. Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]
  3. Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure. [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]
  4. For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies. [ Time Frame: Procedure to 6 months ]

    Assessment Detail:

    Endpoint determined for all patients in whom SpyBite biopsy was taken and observed image features were reported.

    Observed image features include the following categories: None, Growth, Stricture, Hyperplasia, Ulceration, Mass, Dilated tortuous vessels, Papillary or villous projections, Intraductal nodules, Mucus.


  5. For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance. [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]
  6. For patients undergoing stone management: correlation between stone size and ability to reach stone clearance in one SpyGlass session. [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]
  7. For patients undergoing stone management: incidence of visualization of stones not suspected during previous ERCP. [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]

Biospecimen Retention:   Samples Without DNA
Tissue acquisition in the bile ducts


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Age 18 or older.
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281019


Locations
Australia
Royal Adelaide Hospital
Adelaide, Australia
Royal Prince Alfred Hospital
Newtown, Australia
Royal Brisbane and Women's Hospital
Queensland, Australia
Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
India
Postgraduate Institute of Medical Education & Research
Chandigarh, India
Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences
Gurgaon, India
Asian Institute of Gastroenterology
Hyderabad, India
Baldota Institute of Digestive Sciences
Parel, India, 400012
Apollo Gleneagles Hospitals Kolkata
West Bengal, India
Japan
Teikyo University Mizonokuchi Hospital
Kawasaki, Japan
Kinki University School of Medicine
Osaka-sayama, Japan
Tokyo Medical University
Tokyo, Japan
Korea, Republic of
Soon Chun Hyang University Bucheon Hospital
Bucheon, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Pakistan
Civil Hospital- Karachi
Karachi, Pakistan
Saudi Arabia
King Khalid University Hospital
Riyadh, Saudi Arabia
Singapore
Changi General Hospital Pte Ltd.
Singapore, Singapore
South Africa
Netcare Unitas Hospital
Centurion, South Africa
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Benedict Devereaux Royal Brisbane and Women's Hospital
Principal Investigator: James Lau Prince of Wales Hospital
Principal Investigator: Randhir Sud Institute of Digestive & Hepatobiliary Sciences
Principal Investigator: Saad Niaz Civil Hospital- Karachi
Principal Investigator: Abdulrahman Aljebreen King Khalid University Hospital
Principal Investigator: Ang Tiing Leong Changi General Hospital Pte Ltd.
Principal Investigator: Jorg Reichenberger Netcare Unitas Hospital
Principal Investigator: Jong Moon Soon Chun Hyang University
Principal Investigator: Rungsun Rerknimitr King Chulalongkorn Memorial Hospital
Principal Investigator: Ichiro Yasuda Teikyo University Mizonokuchi Hospital
Principal Investigator: Arthur J. Kaffes Royal Prince Alfred Hospital, Sydney, Australia
Principal Investigator: Nam Q. Nguyen Royal Adelaide Hospital
Principal Investigator: Amit Maydeo Baldota Institute of Digestive Sciences
Principal Investigator: Mohan Ramchandani Asian Institute of Gastroenterology
Principal Investigator: Mahesh Goenka Apollo Gleneagles Hospital
Principal Investigator: Professor R. Kochhar Postgraduate Institute of Medical Education & Research
Principal Investigator: Takao Itoi Tokyo Medical University
Principal Investigator: Masayuki Kitano Kinki University School of Medicine
Principal Investigator: Jong K. Lee Samsung Medical Center
Principal Investigator: Dongwan Seo Asan Medical Center

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02281019     History of Changes
Other Study ID Numbers: 90947376
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Hemobilia
Hemorrhage
Pathologic Processes