Development of Applications of the ® PillCam Endoscopy Sy... | NCT02775708

Studies
Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance

NCT02775708

Sponsor

Medtronic - MITG

Status

Completed

Last Update Posted

Nov 1, 2017Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Any Gastric Condition Which Requires Capsule Endoscopy

Interventions

Pillcam endoscopy system

Countries

Germany
Spain

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Sep 19, 2017Actual

Completion Date

Oct 24, 2017Actual

First Submitted Date

Apr 20, 2016

First Submission Date that Met QC Criteria

May 17, 2016

First Posted Date

May 18, 2016Estimated

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

Oct 30, 2017

Last Update Posted Date

Nov 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
capsule endoscopy	Experimental	open label arm ; up to 100 subjects indicated for capsule endoscopy (CE) procedure will undergo the CE procedure with the Pillcam endoscopy system	Device: Pillcam endoscopy system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pillcam endoscopy system	Device		capsule endoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of gaps in the RAPID video will be assessed		capsule endoscopy procedure day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject's from 18 years of age.
Subject is indicated for Capsule Endoscopy procedure.
Subject agrees to sign the Informed Consent Form.

Exclusion Criteria:

Female subject is pregnant.
Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
Subject has a pacemaker or other implanted electro-medical device.
Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
Subject suffers from life threatening conditions.
Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Furth		Fürth		907766	Germany
Hospital De Navarra