Improvement of Colonoscopy Preparation by New Media (APP) (PERICLESAPPI)

July 27, 2015 updated by: Monther Bajbouj, Technical University of Munich

First Experiences With an Offline App (SPA; Smartphone Application) for Colonoscopy Preparation- PERICLES-I APP; Prospective Evaluations of Improvement of Colonocopy Preparation by Optimized Visualization (PERICLES)

Feasibility of an newly programmed offline application for smartphones (SPA, APP) for colonoscopy preparation offering a 5 day guidance prior colonoscopy containing dietary- and behavioral recommendation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

First feasibility testing of a newly programmed app/SPA for android system named Colopr-APP. It is an strictly offline working, autonomous system downloaded to the smartphone. It creates an 5-day guidance prior outpatient colonoscopy with dietary and behavior recommendations.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81675
        • Recruiting
        • 2nd Medical Department, Klinikum rechts der Isar
        • Contact:
        • Principal Investigator:
          • Benjamin Walter, MD
        • Sub-Investigator:
          • von Delius Stefan, MD
        • Sub-Investigator:
          • Katharina Strehle
        • Sub-Investigator:
          • Peter Klare, MD
        • Sub-Investigator:
          • Neu Bruno, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • outpatient colonoscopy
  • smartphone owner with android system

Exclusion Criteria:

  • chronic renal failure
  • anticoagulants
  • pregnancy
  • diabetes mellitus (IDDM)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Regular colonoscopy preparation
Comparison group. Regular colonoscopy preparation
Experimental: APP supported colonoscopy preparation
APP as additional device for colonoscopy preparation
Device: APP supported colonoscopy preparation
additional usage of an app for colonoscopy preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: at day 0 colonoscopy after colonoscopy preparation
feasibility of app supported colonoscopy preparation (stable working and function of software on smartphone)
at day 0 colonoscopy after colonoscopy preparation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel preparation
Time Frame: at day 0 after colonoscopy
Evaluation of bowel preparation during colonoscopy by BostenBowelPreparation Scale
at day 0 after colonoscopy
patient´s satification
Time Frame: day 1 after colonoscopy
Evaluation of patient´s satisfication by a questionaire
day 1 after colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Benjamin M Walter, MD, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERICLES-I-APP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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