SpyGlass AMEA Registry

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2019. 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 (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region

ClinicalTrials.gov ID

NCT02281019

Acronym / sponsor ID

90947376

Conditions

Biliary Stricture, Biliary Obstruction Due to Common Bile Duct Stone, Periampullary Tumor, Hemobilia

Study type

Observational

Recruitment status

Completed

Enrolment

526 participants (actual)

Lead sponsor

Boston Scientific CorporationIndustry (pharma, biotech, devices)

Study start

15 Nov 2014 (actual)

Primary completion

Sep 2016 (actual)

Study completion

18 Oct 2016 (actual)

First posted

3 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.

Study design

Observational model

Case only

Time perspective

Prospective

Target follow-up

6 Months

Number of arms

3

Who may qualify

Ages

18 years and older

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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.

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 10 Jul 2019.
• Derived from this study: PubMed 31250408Maydeo AP, Rerknimitr R, Lau JY, Aljebreen A, Niaz SK, Itoi T, Ang TL, Reichenberger J, Seo DW, Ramchandani MK, Devereaux BM, Lee JK, Goenka MK, Sud R, Nguyen NQ, Kochhar R, Peetermans J, Goswamy PG, Rousseau M, Bhandari SP, Angsuwatcharakon P, Tang RSY, Teoh AYB, Almadi M, Lee YN, Moon JH; SpyGlass AMEA Registry Group. Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates. Endoscopy. 2019 Oct;51(10):922-929. doi: 10.1055/a-0942-9336. Epub 2019 Jun 27.

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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.

20 sites in 10 countries: see every site and its status.