Bowel Preparation for ColonoscopyNCT07337694
Exploring the Clinical Value of an AI-Assisted Patient Self-Assessment App for Bowel Preparation: A Multicenter Study
A study testing The app group in people with Bowel Preparation for Colonoscopy and Colonoscopy, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
The quality of bowel preparation hinges on how well patients follow the prep-drug regimen, so intensive education is essential. Phone calls, texts, short videos, and mini-programs have all been shown to boost compliance and improve prep quality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation for Colonoscopy, Colonoscopy
- What is being tested?
- The app group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Undergoing colonoscopy at a participating site
- Able to defecate in a toilet (or in a setting where stool characteristics can be observed) after taking the bowel-prep solution
- Proficient in using a smartphone
- Willing to participate voluntarily
Who cannot join
- American Society of Anesthesiologists (ASA) class III or IV;
- Gastric-outlet or intestinal obstruction; ③ Active gastrointestinal bleeding; ④ Enterostomy (colostomy/ileostomy); ⑤ Status post total colectomy.
About this study
The quality of bowel preparation hinges on how well patients follow the prep-drug regimen, so intensive education is essential. Phone calls, texts, short videos, and mini-programs have all been shown to boost compliance and improve prep quality. Still, we also need a way to spot-early-those patients who are likely to prep poorly so we can step in with a rescue plan.
In our pilot work the investigators built an AI-assisted mini-program that lets patients photograph their effluent and get an instant quality read-out. The single-center RCT showed excellent performance. Because these findings came from one center, the investigators are now launching a multicenter study to test the tool more broadly. Patients will use the AI mini-program at home; if the algorithm predicts inadequate prep it will prompt them to come in early or alert staff so the investigators can initiate a rescue protocol and, ultimately, improve bowel-cleansing quality.
- Conditions
- Bowel Preparation for Colonoscopy, Colonoscopy
- Being tested
- The app group
- Keywords
- Bowel preparation, Colonoscopy, Artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The app groupOther
After taking the bowel-prep solution, patients in the app group are instructed to photograph their final stool in the toilet and upload the image through our smartphone app. The AI algorithm immediately scores the prep quality. If the image is rated "poor" or "inadequate," the app displays an alert advising the patient to come to the hospital early or contact clinical staff; clinical staffs then review the photo and decide whether a rescue preparation is needed. The standard rescue was an additional packet of polyethylene glycol. If the image is rated "adequate," the patient is told the prep is acceptable and should proceed to the appointment, where clinical staffs will use the uploaded photo to confirm eligibility for colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| The App group | Experimental | After taking the bowel-prep solution, patients in the app group are instructed to photograph their final stool in the toilet and upload the image through our smartphone app. The AI algorithm immediately scores the prep quality. If the image is rated "poor" or "inadequate," the app displays an alert advising the patient to come to the hospital early or contact clinical staff; clinical staffs then review the photo and decide whether a rescue preparation is needed. The standard rescue was an additional packet of polyethylene glycol. If the image is rated "adequate," the patient is told the prep is acceptable and should proceed to the appointment, where clinical staffs will use the uploaded photo to confirm eligibility for colonoscopy. Receives: Other: The app group |
| The control group | No intervention | The control group followed the conventional procedure: before the examination, clinical staffs asked questions and relied on the patient's verbal description of their stool to judge the adequacy of bowel preparation. If the prep was deemed inadequate, the standard rescue was an additional packet of polyethylene glycol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the bowel preparation quality between the app group and the control group.
The rate of adequate and excellent bowel preparation.
Measured: Periprocedural
Secondary outcomes (10)
Evaluate the diagnostic performance of the app-based assessment.
Sensitivity, specificity, negative predictive value, positive predictive value
Measured: Periprocedural
cecal intubation rate
Measured: Periprocedural
cecal intubation time
Measured: Periprocedural
withdrawal time (excluding polypectomy and biopsy)
Measured: Periprocedural
polyp-detection rate (PDR), adenoma-detection rate (ADR), advanced-adenoma-detection rate (aADR)
Measured: Periprocedural
rate of rescue preparation due to inadequate preparation
Measured: Periprocedural
clinical staffs' assessment time
Measured: Periprocedural
User satisfaction score
From 0 to 10, 0 stands for the least satisfaction, and 10 stands for the most satisfaction.
Measured: Periprocedural
post-procedural adverse events
Measured: From enrollment to 30 days after the procedure.
rate of rescheduled examinations due to inadequate preparation
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Haihe Hospital, Guangdong Second Provincial General Hospital, Dongguan Hospital of Traditional Chinese Medicine, Cangzhou Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337694
- Sponsor's protocol ID
- 2025ZSLYEC-747
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Clinical Value of an AI-Assisted Patient Self-Assessment App for Bowel Preparation: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07337694
- Acronym / sponsor ID
- 2025ZSLYEC-747
- Conditions
- Bowel Preparation for Colonoscopy, Colonoscopy
- Keywords
- Bowel preparation, Colonoscopy, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Tianjin Haihe Hospital, Guangdong Second Provincial General Hospital, Dongguan Hospital of Traditional Chinese Medicine, Cangzhou Central Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- 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.
The quality of bowel preparation hinges on how well patients follow the prep-drug regimen, so intensive education is essential. Phone calls, texts, short videos, and mini-programs have all been shown to boost compliance and improve prep quality. Still, we also need a way to spot-early-those patients who are likely to prep poorly so we can step in with a rescue plan.
In our pilot work the investigators built an AI-assisted mini-program that lets patients photograph their effluent and get an instant quality read-out. The single-center RCT showed excellent performance. Because these findings came from one center, the investigators are now launching a multicenter study to test the tool more broadly. Patients will use the AI mini-program at home; if the algorithm predicts inadequate prep it will prompt them to come in early or alert staff so the investigators can initiate a rescue protocol and, ultimately, improve bowel-cleansing quality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The App group | Experimental | Other: The app groupAfter taking the bowel-prep solution, patients in the app group are instructed to photograph their final stool in the toilet and upload the image through our smartphone app. The AI algorithm immediately scores the prep quality. If the image is rated "poor" or "inadequate," the app displays an alert advising the patient to come to the hospital early or contact clinical staff; clinical staffs then review the photo and decide whether a rescue preparation is needed. The standard rescue was an additional packet of polyethylene glycol. If the image is rated "adequate," the patient is told the prep is acceptable and should proceed to the appointment, where clinical staffs will use the uploaded photo to confirm eligibility for colonoscopy. |
| The control group | No intervention | –The control group followed the conventional procedure: before the examination, clinical staffs asked questions and relied on the patient's verbal description of their stool to judge the adequacy of bowel preparation. If the prep was deemed inadequate, the standard rescue was an additional packet of polyethylene glycol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Undergoing colonoscopy at a participating site
- Able to defecate in a toilet (or in a setting where stool characteristics can be observed) after taking the bowel-prep solution
- Proficient in using a smartphone
- Willing to participate voluntarily
Key exclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) class III or IV;
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 |
|---|---|---|
| The app groupAfter taking the bowel-prep solution, patients in the app group are instructed to photograph their final stool in the toilet and upload the image through our smartphone app. The AI algorithm immediately scores the prep quality. If the image is rated "poor" or "inadequate," the app displays an alert advising the patient to come to the hospital early or contact clinical staff; clinical staffs then review the photo and decide whether a rescue preparation is needed. The standard rescue was an additional packet of polyethylene glycol. If the image is rated "adequate," the patient is told the prep is acceptable and should proceed to the appointment, where clinical staffs will use the uploaded photo to confirm eligibility for colonoscopy. | Other | The App group |
Primary outcome
Compare the bowel preparation quality between the app group and the control group.
Time frame: Periprocedural
The rate of adequate and excellent bowel preparation.
10 secondary outcomes
Evaluate the diagnostic performance of the app-based assessment.
Time frame: Periprocedural
cecal intubation rate
Time frame: Periprocedural
cecal intubation time
Time frame: Periprocedural
withdrawal time (excluding polypectomy and biopsy)
Time frame: Periprocedural
polyp-detection rate (PDR), adenoma-detection rate (ADR), advanced-adenoma-detection rate (aADR)
Time frame: Periprocedural
rate of rescue preparation due to inadequate preparation
Time frame: Periprocedural
clinical staffs' assessment time
Time frame: Periprocedural
User satisfaction score
Time frame: Periprocedural
post-procedural adverse events
Time frame: From enrollment to 30 days after the procedure.
rate of rescheduled examinations due to inadequate preparation
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The app group in people with Bowel Preparation for Colonoscopy and Colonoscopy, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the bowel preparation quality between the app group and the control group. (time frame: Periprocedural). 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 21 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.