- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01937819
Patients Judging Bowel Preparation by Using SMARTPHONE Application (BPBUSA)
Patients Judging Dose Adjustment of Bowel Preparation Solution for Bowel Preparation by Using SMARTPHONE Application: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Busan, Korea, Republic of, 612-896
- Haeundae Paik Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient who are scheduled for colonoscopy Available to use the SMARTPHONE application and smartphone camera
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SMART arm
Using SMARTPHONE application for self judging bowel preparation
|
The SMARTPHONE application for self judging bowel preparation by taking the picture of stool form.
Other Names:
|
|
No Intervention: Conventional arm
Non-using SMARTPHONE application for bowel preparation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
bowel cleaning quality according to Ottawa scale scores
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The consistency of bowel cleansing result by SMARTPHONE application with Ottawa scale scores by colonoscopy
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SMART-BP01
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