NCT04580940

Brief Summary

To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series

Trial Health

93
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
7 countries

7 active sites

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

First Submitted

Initial submission to the registry

September 23, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

July 27, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

September 23, 2020

Last Update Submit

November 27, 2023

Conditions

Pancreatic DiseasesBile Duct ObstructionBile Duct Diseases

Keywords

Percutaneous transhepatic cholangiopancreatoscopyspyglass discoverpancreaticobiliary disease

Outcome Measures

Primary Outcomes (1)

  • Achieving clinical intent of procedure as indicated

    Physicians will report achieving clinical success by recording the completed procedures compared to procedures planned by 30 days (+/- 3 days) after index PTCS.

    1 month

Secondary Outcomes (5)

  • Number of Adverse Events

    1 month

  • Technical success

    During index procedure

  • Procedural Time

    During index procedure

  • Number of PTCS procedures

    1 month

  • Endoscopist rating

    During index procedure

Study Arms (1)

Subjects with complex pancreaticobiliary disease

All subjects will undergo the percutaneous transhepatic cholangiopancreatoscopy with the SpyGlass Discover System.

Device: SpyGlass™ Discover Digital System

Interventions

SpyGlass™ Discover Digital SystemDEVICE

Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.

Subjects with complex pancreaticobiliary disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with complex pancreaticobiliary disease

You may qualify if:

  • Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice
  • Written informed consent from patient or legally authorized representative of the patient

You may not qualify if:

  • Contraindication for cholangiopancreatoscopy
  • Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access
  • \<18 years of age
  • Potentially vulnerable subjects, including, but not limited to pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Erasme University Hospital

Brussels, 1070, Belgium

Location

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G2N2, Canada

Location

Evangelisches Krakenhaus Düsseldorf

Düsseldorf, 40217, Germany

Location

Prince of Wales Hospital

Shatin, NewTerritories, 999077, Hong Kong

Location

Asian Institute of Gastroenterology

Hyderabad, Somajiguda, 500-082, India

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

Related Publications (2)

  • Boskoski I, Beyna T, Lau JY, Lemmers A, Fotoohi M, Ramchandani M, Pontecorvi V, Peetermans J, Shlomovitz E. Efficacy and safety of a single-use cholangioscope for percutaneous transhepatic cholangioscopy. Endosc Int Open. 2024 Aug 23;12(8):E981-E988. doi: 10.1055/a-2366-2265. eCollection 2024 Aug.

    PMID: 39184059DERIVED

  • Aihara H, Othman MO, Jawaid SA, Gorgun E, Sharma NR, Siddiqui UD, Peetermans JA, Rousseau MJ, Nishimura M. A multicenter, retrospective study of a through-the-needle injection-capable electrosurgical knife for endoscopic submucosal dissection. Gastrointest Endosc. 2024 Dec;100(6):1034-1042. doi: 10.1016/j.gie.2024.06.011. Epub 2024 Jun 13.

    PMID: 38879045DERIVED

MeSH Terms

Conditions

Pancreatic DiseasesCholestasisBile Duct Diseases

Condition Hierarchy (Ancestors)

Digestive System DiseasesBiliary Tract Diseases

Study Officials

  • Ivo Boskoski, MD, PhD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

  • Torsten Beyna, MD, PhD

    Evangelisches Krakenhaus Düsseldorf

    PRINCIPAL INVESTIGATOR

  • Mehran Fotoohi, MD, PhD

    Virginia Mason

    PRINCIPAL INVESTIGATOR

  • Arnaud Lemmers, MD, PhD

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

  • James Lau, MD, PhD

    Prince of Wales Hospital

    PRINCIPAL INVESTIGATOR

  • Eran Shlomovitz, MD, PhD

    Toronto General Hospital, University Health Network

    PRINCIPAL INVESTIGATOR

  • Mohan Ramchandani, MD, PhD

    Asian Institute of Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 9, 2020

Study Start

July 27, 2021

Primary Completion

December 14, 2022

Study Completion

January 14, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

DE(1)BE(1)HK(1)IT(1)IN(1)US(1)CA(1)