BOWEL PREPARATION (BOWEL CLEANSING)BPBUSANCT01937819
Patients Judging Bowel Preparation by Using SMARTPHONE Application
A study testing SMART arm in people with BOWEL PREPARATION (BOWEL CLEANSING), run by Inje University at 1 site in South Korea.
Trial summary
High-quality bowel preparation is a prerequisite for colonoscopy. Few studies have evaluated visual aids as a means of improving the quality of bowel preparation. We assess the effect of patient-judging dose adjustment of bowel preparation solution for bowel preparation using SMARTPHONE application on the quality of… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- BOWEL PREPARATION (BOWEL CLEANSING)
- What is being tested?
- SMART arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Feb 2014
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient who are scheduled for colonoscopy Available to use the SMARTPHONE application and smartphone camera
Who cannot join
- known or suspected bowel obstruction known pregnancy, breast feeding known allergy to PEG presence of severe illness(renal failure, congestive heart failure, liver failure,), refusal of consent to participate in the study not available to use the SMARTPHONE application and SMARTPHONE camera
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Haeundae Paik Hospital
Busan, 612-896
Jongha Park, M.D., +82-51-797-0200, neakker@gmail.com
Gijung Jeon, M.D., +82-51-797-0200, elecyx@naver.com
About this study
Official title: Patients Judging Dose Adjustment of Bowel Preparation Solution for Bowel Preparation by Using SMARTPHONE Application: A Pilot Study
High-quality bowel preparation is a prerequisite for colonoscopy. Few studies have evaluated visual aids as a means of improving the quality of bowel preparation. We assess the effect of patient-judging dose adjustment of bowel preparation solution for bowel preparation using SMARTPHONE application on the quality of bowel preparation.
Read the detailed description
This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of SMARTPHONE application on the bowel cleansing was inspected.
A intervention patients take the picture of stool using SMARTPHONE camera application, and then assess the bowel cleansing result. If the result is "Pass", they stop the addition of bowel preparation agent. but the result is "Fail", so they have the additive bowel preparation agent and repeat using the SMARTPHONE application.
After the bowel preparation, Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale after procedure.
- Conditions
- BOWEL PREPARATION (BOWEL CLEANSING)
- Being tested
- SMART arm
- Keywords
- BOWEL PREPARATION, SMARTPHONE APPLICATION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART armDevice
Also called SMART-BP
The SMARTPHONE application for self judging bowel preparation by taking the picture of stool form.
| Study group | Role | What they receive |
|---|---|---|
| SMART arm | Experimental | Using SMARTPHONE application for self judging bowel preparation Receives: Device: SMART arm |
| Conventional arm | No intervention | Non-using SMARTPHONE application for bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel cleaning quality according to Ottawa scale scores
Measured: 3 months
Secondary outcomes (1)
The consistency of bowel cleansing result by SMARTPHONE application with Ottawa scale scores by colonoscopy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BOWEL PREPARATION (BOWEL CLEANSING)Studies of the same condition, open and under way.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jongha Park, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937819
- Sponsor's protocol ID
- SMART-BP01
- Acronym
- BPBUSA
- Status last verified
- Sep 2013
- First submitted
- 4 Sep 2013
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Judging Dose Adjustment of Bowel Preparation Solution for Bowel Preparation by Using SMARTPHONE Application: A Pilot Study
- ClinicalTrials.gov ID
- NCT01937819
- Acronym / sponsor ID
- BPBUSA / SMART-BP01
- Conditions
- BOWEL PREPARATION (BOWEL CLEANSING)
- Keywords
- BOWEL PREPARATION, SMARTPHONE APPLICATION
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 10 Sep 2013 (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.
High-quality bowel preparation is a prerequisite for colonoscopy. Few studies have evaluated visual aids as a means of improving the quality of bowel preparation. We assess the effect of patient-judging dose adjustment of bowel preparation solution for bowel preparation using SMARTPHONE application on the quality of bowel preparation.
Detailed description
This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of SMARTPHONE application on the bowel cleansing was inspected.
A intervention patients take the picture of stool using SMARTPHONE camera application, and then assess the bowel cleansing result. If the result is "Pass", they stop the addition of bowel preparation agent. but the result is "Fail", so they have the additive bowel preparation agent and repeat using the SMARTPHONE application.
After the bowel preparation, Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale after procedure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART arm | Experimental | Device: SMART armUsing SMARTPHONE application for self judging bowel preparation |
| Conventional arm | No intervention | –Non-using SMARTPHONE application for bowel preparation |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who are scheduled for colonoscopy Available to use the SMARTPHONE application and smartphone camera
Key exclusion criteria (1 listed)
- known or suspected bowel obstruction known pregnancy, breast feeding known allergy to PEG presence of severe illness(renal failure, congestive heart failure, liver failure,), refusal of consent to participate in the study not available to use the SMARTPHONE application and SMARTPHONE camera
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 |
|---|---|---|
| SMART armAlso: SMART-BPThe SMARTPHONE application for self judging bowel preparation by taking the picture of stool form. | Device | SMART arm |
Primary outcome
bowel cleaning quality according to Ottawa scale scores
Time frame: 3 months
1 secondary outcome
The consistency of bowel cleansing result by SMARTPHONE application with Ottawa scale scores by colonoscopy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART arm in people with BOWEL PREPARATION (BOWEL CLEANSING), run by Inje University at 1 site in South Korea.
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 1 inclusion and 1 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 10 Sep 2013. 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 South Korea. 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.
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 Jongha Park, M.D. (+82-51-797-0200, neakker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bowel cleaning quality according to Ottawa scale scores (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2013.