NCT02775708

Brief Summary

The purpose of this study is to support development of PillCam Endoscopy System applications.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
2 countries

2 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

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2017

Completed
Last Updated

November 1, 2017

Status Verified

September 1, 2017

Enrollment Period

1.6 years

First QC Date

April 20, 2016

Last Update Submit

October 30, 2017

Conditions

Any Gastric Condition Which Requires Capsule Endoscopy

Outcome Measures

Primary Outcomes (1)

  • Number of gaps in the RAPID video will be assessed

    capsule endoscopy procedure day

Study Arms (1)

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

Pillcam endoscopy systemDEVICE
capsule endoscopy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinikum Furth

Fürth, 907766, Germany

Location

Hospital De Navarra

Pamplona, Navarre, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2016

First Posted

May 18, 2016

Study Start

March 1, 2016

Primary Completion

September 19, 2017

Study Completion

October 24, 2017

Last Updated

November 1, 2017

Record last verified: 2017-09

Locations

DE(1)ES(1)