- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02512328
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 Contact
- Name: Benjamin M Walter, MD
- Phone Number: 0049-89-4140-2251
- Email: Benjamin.Walter@lrz.tum.de
Study Locations
-
-
-
Munich, Germany, 81675
- Recruiting
- 2nd Medical Department, Klinikum rechts der Isar
-
Contact:
- Benjamin M Walter, MD
- Phone Number: +49-89-4140-2223
- Email: Benjamin.Walter@lrz.tum.de
-
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
|
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
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.
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
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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