NCT02967926

Brief Summary

This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal without fluoroscopy

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

November 3, 2016

Last Update Submit

November 16, 2016

Conditions

Common Bile Duct DiseasesStone - BiliaryCholangitis, Sclerosing

Keywords

common bile duct stonecholangioscopySpyGlassnon-fluoroscopic

Outcome Measures

Primary Outcomes (1)

  • Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal

    1 year

Secondary Outcomes (1)

  • Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal

    1 year

Other Outcomes (1)

  • Procedural time

    1 year

Study Arms (1)

ERCP without Fluoroscopy

EXPERIMENTAL

Non-fluoroscopic common bile duct stone extraction

Procedure: Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)

Interventions

Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)PROCEDURE

Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal

ERCP without Fluoroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinically suspected/confirmed CBDS
  • CBD caliber 5-15 mm

You may not qualify if:

  • History of bile duct surgery
  • History of bile duct tumor
  • History of bile duct stricture
  • Severe comorbidity
  • Unstable vital signs
  • Pregnancy
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Common Bile Duct DiseasesCholecystolithiasisCholangitis, SclerosingGallstones

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisGallbladder DiseasesCholangitisCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastrointestinal Endoscopy Excellence Center

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 18, 2016

Study Start

December 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

November 18, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share