Gastrointestinal NeoplasmsPhase 1PERICLESAPPINCT02512328
Improvement of Colonoscopy Preparation by New Media (APP)
A Phase 1 study testing APP supported colonoscopy preparation in people with Gastrointestinal Neoplasms, run by Technical University of Munich at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- APP supported colonoscopy preparation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatient colonoscopy
- smartphone owner with android system
Who cannot join
- chronic renal failure
- anticoagulants
- pregnancy
- diabetes mellitus (IDDM)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
2nd Medical Department, Klinikum rechts der Isar
Munich, 81675
Benjamin M Walter, MD, +49-89-4140-2223, Benjamin.Walter@lrz.tum.de
Benjamin Walter, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Neoplasms
- Being tested
- APP supported colonoscopy preparation
- Keywords
- Colonoscopy, new media, APP, colonoscopy preparation, SPA, smartphone application
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP supported colonoscopy preparationDevice
additional usage of an app for colonoscopy preparation
| Study group | Role | What they receive |
|---|---|---|
| Regular colonoscopy preparation | No intervention | Comparison group. Regular colonoscopy preparation |
| APP supported colonoscopy preparation | Experimental | APP as additional device for colonoscopy preparation Receives: Device: APP supported colonoscopy preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
feasibility of app supported colonoscopy preparation (stable working and function of software on smartphone)
Measured: at day 0 colonoscopy after colonoscopy preparation
Secondary outcomes (2)
Bowel preparation
Evaluation of bowel preparation during colonoscopy by BostenBowelPreparation Scale
Measured: at day 0 after colonoscopy
patient´s satification
Evaluation of patient´s satisfication by a questionaire
Measured: day 1 after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monther Bajbouj, Technical University of Munich
- Investigators
- Benjamin M Walter, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512328
- Sponsor's protocol ID
- PERICLES-I-APP
- Acronym
- PERICLESAPPI
- Status last verified
- Jul 2015
- First submitted
- 24 Feb 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Walter B, Schmid R, von Delius S. A Smartphone App for Improvement of Colonoscopy Preparation (ColoprAPP): Development and Feasibility Study. JMIR Mhealth Uhealth. 2017 Sep 20;5(9):e138. doi: 10.2196/mhealth.7703.
PubMed 28931498
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02512328
- Acronym / sponsor ID
- PERICLESAPPI / PERICLES-I-APP
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- Colonoscopy, new media, APP, colonoscopy preparation, SPA, smartphone application
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular colonoscopy preparation | No intervention | –Comparison group. Regular colonoscopy preparation |
| APP supported colonoscopy preparation | Experimental | Device: APP supported colonoscopy preparationAPP as additional device for colonoscopy preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- outpatient colonoscopy
- smartphone owner with android system
Key exclusion criteria (4 listed)
- chronic renal failure
- anticoagulants
- pregnancy
- diabetes mellitus (IDDM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APP supported colonoscopy preparationadditional usage of an app for colonoscopy preparation | Device | APP supported colonoscopy preparation |
Primary outcome
Feasibility
Time frame: at day 0 colonoscopy after colonoscopy preparation
feasibility of app supported colonoscopy preparation (stable working and function of software on smartphone)
2 secondary outcomes
Bowel preparation
Time frame: at day 0 after colonoscopy
patient´s satification
Time frame: day 1 after colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Derived from this study: PubMed 28931498Walter B, Schmid R, von Delius S. A Smartphone App for Improvement of Colonoscopy Preparation (ColoprAPP): Development and Feasibility Study. JMIR Mhealth Uhealth. 2017 Sep 20;5(9):e138. doi: 10.2196/mhealth.7703.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Walter, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APP supported colonoscopy preparation in people with Gastrointestinal Neoplasms, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin M Walter, MD (0049-89-4140-2251, Benjamin.Walter@lrz.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: at day 0 colonoscopy after colonoscopy preparation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02512328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.