Motorized Spiral Enteroscopy-assisted ERCP in Surgically... | NCT04912440

Studies
Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy

NCT04912440

Sponsor

Evangelisches Krankenhaus Düsseldorf

Status

Unknown status

Last Update Posted

Jun 21, 2021Actual

Enrollment

35Estimated

Phase

Not provided

Conditions

Ercp in Altered Anatomy

Interventions

MSE-ERCP

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2021Estimated

Primary Completion Date

Sep 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

May 28, 2021

First Submission Date that Met QC Criteria

May 28, 2021

First Posted Date

Jun 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2021

Last Update Posted Date

Jun 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with surgically altered anatomy receiving Motorized Spiral Eneroscopy (MSE)-assisted ERCP at a single endoscopic reference center for various indications are planned to be retrospectively enrolled

Detailed Description

All consecutive patients with altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery and indication for ERCP with biliary and/or pancreatic indication, who underwent routine Enteroscopy-assisted ERCP using MSE, at the study center during the study period, will be enrolled in the analysis.

Primary endpoint of the study will be efficacy and safety of MSE-assisted ERCP.

Retrospective epidemiologic Study (not interventional) was approved by local IRB and ethical committee of the North-Rhine Chamber of Physicians (Düsseldorf, Germany), Reference Number: 177/2021.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MSE-ERCP		Group of patients, that received motorized spiral enteroscopy assisted ERCP in altered anatomy at the single study center	Device: MSE-ERCP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MSE-ERCP	Device	No interventional study, MSE-ERCP performed within routine treatment, (approved indication of device)	MSE-ERCP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate of MSE-ERCP	rate of subjects with successfull MSE-assisted ERCP	intraprocedural
Adverse event rate of MSE-ERCP	rate of adverse events during and early after MSE-ERCP	3 days

Secondary Outcomes

Measure	Description	Time Frame
Success rate of enteroscopy	rate of subjects with successful enteroscopic access to the papilla	intraprocedural
Procedural duration	overall time for MSE-ERCP (scope in to scope out)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery
indication for ERCP with biliary and/or pancreatic indication
Enteroscopy-assisted ERCP using MSE, at the study center during the study period

Exclusion Criteria:

- due to the retrospective design of the study, no exclusion criteria are defined

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with surgically altered upper gastrointestinal anatomy and indication for endoscopic retrograde cholangio-pancreatography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Torsten Beyna, MD PhD	Contact	00492119191605		torsten.beyna@evk-duesseldorf.de
Markus Schneider, MD	Contact	00492119191605		markus.schneider@evk-duesseldorf.de

Overall Officials

Name	Affiliation	Role
Torsten Beyna, MD PhD	Evangelisches Krankenhaus Düsseldorf, Department of Gastroenterology and Therapeutic Endoscopy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Evangelisches Krankenhaus		Düsseldorf		40217	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

No exchange of individual data is planned

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided