Cleansing Quality of the ColonCALPER3NCT05871814
Artificial Intelligence and Bowel Cleansing Quality
A study testing Colon preparation guided by an artificial intelligence device in people with Cleansing Quality of the Colon, run by University of La Laguna at 1 site in Spain.
Trial summary
The main purpose of the study is to assess if a strategy based on a mobile application linked to a neural network is useful for guiding colon cleansing in a more personalized way is better than the usual care defined as regular oral and written instructions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cleansing Quality of the Colon
- What is being tested?
- Colon preparation guided by an artificial intelligence device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2023to 31 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Patients referred for outpatient colonoscopy
- Sign informed consent
Who cannot join
- Incomplete colonoscopy (except for poor bowel preparation)
- Contraindication for colonoscopy
- Allergies.
- Refusal to participate in the study or impairment to sign the informed consent.
- Colectomy (more than 1 segment)
- Dementia with difficulty in the intake of the preparation.
- Inability to use the smartphone application
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
About this study
Official title: Strategy for Decreasing Inadequate Bowel Cleansing in Colonoscopy Based on an Artificial Intelligence System: A Randomized and Controlled Study
The main purpose of the study is to assess if a strategy based on a mobile application linked to a neural network is useful for guiding colon cleansing in a more personalized way is better than the usual care defined as regular oral and written instructions. The secondary aim will be the acceptance of this artificial intelligence device defined as the proportion of patients assigned to the intervention group that actually used the device.
Read the detailed description
The patient's perception of colon cleanliness prior to undergoing a colonoscopy has been studied as a predictor of colon cleanliness quality, demonstrating to be a powerful predictor of inadequate cleanliness. A convolutional neural network developed by our group, trained with photographs of rectal effluents at different moments of colon preparation, has achieved high diagnostic accuracy. Based on all this experience, the next step would be to evaluate in a randomized clinical trial whether this neural network integrated into a computer application associated with cleaning recommendations improves the colon cleanliness quality of patients compared to a control group, being the objective of this project Therefore, the main purpose of the study is to assess if a strategy based on a mobile application linked to a neural network is useful for guiding colon cleansing in a more personalized way is better than the usual care defined as regular oral and written instructions. The secondary aim will be the acceptance of this artificial intelligence device defined as the proportion of patients assigned to the intervention group that actually used the device. Consecutive outpatient patients meeting inclusion criteria and none of the exclusion criteria who have been requested to undergo colonoscopy will be included in the study and randomized to mobile artificial intelligence application or control group The intervention group will receive a response from the AI system in order to determine the quality of colon cleansing: adequate preparation or inadequate preparation. In addition, the system will issue specific recommendations based on the quality of cleansing. Patients assigned to the control group will undergo colonoscopy preparation according to standard recommendations.
- Conditions
- Cleansing Quality of the Colon
- Being tested
- Colon preparation guided by an artificial intelligence device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon preparation guided by an artificial intelligence deviceDevice
Regular oral and written information will be provided to this group. In addition, participants will take a picture of the last rectal effluent with the smart phone that have to upload to a server. A convolutional neural network will assess whether the bowel preparation is correct or not (clean or not). The system will issue specific recommendations based on the quality of cleansing
| Study group | Role | What they receive |
|---|---|---|
| Colon preparation guided by an artificial intelligence device | Experimental | Regular oral and written information will be provided to this group. In addition, participants will take a picture of the last rectal effluent with the smart phone that have to upload to a server. A convolutional neural network will assess whether the bowel preparation is correct or not (clean or not). The system will issue specific recommendations based on the quality of cleansing. Receives: Device: Colon preparation guided by an artificial intelligence device |
| Control group | Active comparator | Regular oral and written information will be provided to this group Receives: Device: Colon preparation guided by an artificial intelligence device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale
The Boston Bowel Preparation Scale assesses the quality of bowel cleansing in the three segments of the colon (proximal, transverse, and distal) on a scale of 0 (no preparation) to 3 points (excellent preparation), with a maximum score of 9 points.
Measured: 3 months
Secondary outcomes (1)
Participation rate
Proportion of participants assigned to the intervention group who used the device. It will be assessed by self-reported information from the patients and by the presence of a picture in a server for the storage of images.
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 posted23 May 2023
- Study start15 Sep 2023
- Primary completion30 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cleansing Quality of the ColonStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of La Laguna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Hernandez-Guerra, MD, University of La Laguna
- Investigators
- Antonio Z Gimeno García, MD, PhD, Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871814
- Sponsor's protocol ID
- Bowel Cleansing application
- Acronym
- CALPER3
- Status last verified
- Jun 2025
- First submitted
- 13 May 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gimeno-Garcia AZ, Benitez-Zafra F, Hernandez A, Hernandez-Negrin D, Nicolas-Perez D, Hernandez G, Baute-Dorta JL, Cedres Y, Del-Castillo R, Mon J, Jimenez A, Navarro-Davila MA, Rodriguez-Hernandez E, Alarcon O, Romero R, Felipe V, Segura N, Hernandez-Guerra M. Agreement between the perception of colon cleansing reported by patients and colon cleansing assessed by a validated colon cleansing scale. Gastroenterol Hepatol. 2024 Feb;47(2):130-139. doi: 10.1016/j.gastrohep.2023.02.009. Epub 2023 Mar 2. English, Spanish.
PubMed 36870478Berzin TM, Parasa S, Wallace MB, Gross SA, Repici A, Sharma P. Position statement on priorities for artificial intelligence in GI endoscopy: a report by the ASGE Task Force. Gastrointest Endosc. 2020 Oct;92(4):951-959. doi: 10.1016/j.gie.2020.06.035. Epub 2020 Jun 19.
PubMed 32565188Mori Y, East JE, Hassan C, Halvorsen N, Berzin TM, Byrne M, von Renteln D, Hewett DG, Repici A, Ramchandani M, Al Khatry M, Kudo SE, Wang P, Yu H, Saito Y, Misawa M, Parasa S, Matsubayashi CO, Ogata H, Tajiri H, Pausawasdi N, Dekker E, Ahmad OF, Sharma P, Rex DK. Benefits and challenges in implementation of artificial intelligence in colonoscopy: World Endoscopy Organization position statement. Dig Endosc. 2023 May;35(4):422-429. doi: 10.1111/den.14531. Epub 2023 Mar 13.
PubMed 36749036Gimeno-Garcia AZ, Benitez-Zafra F, Redondo-Zaera I, Cruz-Perdomo N, Bautista M, Morales-Arraez D, Pardo-Balteiro A, Borque P, Navarro-Davila MA, Jimenez-Sosa A, Berenguer R, Tellechea J, Alayon-Miranda S, Mon J, Romero A, Alvarez L, Castillo RD, Perdomo A, Hernandez-Negrin D, Gamez S, Cedres Y, Quintana-Diaz PH, Perez-Gonzalez F, Nicolas-Perez D, Hernandez-Guerra M. An Artificial Intelligence-Guided Strategy to Reduce Poor Bowel Preparation: A Multicenter Randomized Controlled Study. Am J Gastroenterol. 2026 Apr 1;121(4):890-898. doi: 10.14309/ajg.0000000000003921. Epub 2026 Jan 20.
PubMed 41556527
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Decreasing Inadequate Bowel Cleansing in Colonoscopy Based on an Artificial Intelligence System: A Randomized and Controlled Study
- ClinicalTrials.gov ID
- NCT05871814
- Acronym / sponsor ID
- CALPER3 / Bowel Cleansing application
- Conditions
- Cleansing Quality of the Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 23 May 2023 (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 main purpose of the study is to assess if a strategy based on a mobile application linked to a neural network is useful for guiding colon cleansing in a more personalized way is better than the usual care defined as regular oral and written instructions. The secondary aim will be the acceptance of this artificial intelligence device defined as the proportion of patients assigned to the intervention group that actually used the device.
Detailed description
The patient's perception of colon cleanliness prior to undergoing a colonoscopy has been studied as a predictor of colon cleanliness quality, demonstrating to be a powerful predictor of inadequate cleanliness. A convolutional neural network developed by our group, trained with photographs of rectal effluents at different moments of colon preparation, has achieved high diagnostic accuracy. Based on all this experience, the next step would be to evaluate in a randomized clinical trial whether this neural network integrated into a computer application associated with cleaning recommendations improves the colon cleanliness quality of patients compared to a control group, being the objective of this project Therefore, the main purpose of the study is to assess if a strategy based on a mobile application linked to a neural network is useful for guiding colon cleansing in a more personalized way is better than the usual care defined as regular oral and written instructions. The secondary aim will be the acceptance of this artificial intelligence device defined as the proportion of patients assigned to the intervention group that actually used the device. Consecutive outpatient patients meeting inclusion criteria and none of the exclusion criteria who have been requested to undergo colonoscopy will be included in the study and randomized to mobile artificial intelligence application or control group The intervention group will receive a response from the AI system in order to determine the quality of colon cleansing: adequate preparation or inadequate preparation. In addition, the system will issue specific recommendations based on the quality of cleansing. Patients assigned to the control group will undergo colonoscopy preparation according to standard recommendations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colon preparation guided by an artificial intelligence device | Experimental | Device: Colon preparation guided by an artificial intelligence deviceRegular oral and written information will be provided to this group. In addition, participants will take a picture of the last rectal effluent with the smart phone that have to upload to a server. A convolutional neural network will assess whether the bowel preparation is correct or not (clean or not). The system will issue specific recommendations based on the quality of cleansing. |
| Control group | Active comparator | Device: Colon preparation guided by an artificial intelligence deviceRegular oral and written information will be provided to this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Patients referred for outpatient colonoscopy
- Sign informed consent
Key exclusion criteria (7 listed)
- Incomplete colonoscopy (except for poor bowel preparation)
- Contraindication for colonoscopy
- Allergies.
- Refusal to participate in the study or impairment to sign the informed consent.
- Colectomy (more than 1 segment)
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 |
|---|---|---|
| Colon preparation guided by an artificial intelligence deviceRegular oral and written information will be provided to this group. In addition, participants will take a picture of the last rectal effluent with the smart phone that have to upload to a server. A convolutional neural network will assess whether the bowel preparation is correct or not (clean or not). The system will issue specific recommendations based on the quality of cleansing | Device | Colon preparation guided by an artificial intelligence device, Control group |
Primary outcome
Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale
Time frame: 3 months
The Boston Bowel Preparation Scale assesses the quality of bowel cleansing in the three segments of the colon (proximal, transverse, and distal) on a scale of 0 (no preparation) to 3 points (excellent preparation), with a maximum score of 9 points.
1 secondary outcome
Participation rate
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Results publication: PubMed 36870478Gimeno-Garcia AZ, Benitez-Zafra F, Hernandez A, Hernandez-Negrin D, Nicolas-Perez D, Hernandez G, Baute-Dorta JL, Cedres Y, Del-Castillo R, Mon J, Jimenez A, Navarro-Davila MA, Rodriguez-Hernandez E, Alarcon O, Romero R, Felipe V, Segura N, Hernandez-Guerra M. Agreement between the perception of colon cleansing reported by patients and colon cleansing assessed by a validated colon cleansing scale. Gastroenterol Hepatol. 2024 Feb;47(2):130-139. doi: 10.1016/j.gastrohep.2023.02.009. Epub 2023 Mar 2. English, Spanish.
- Results publication: PubMed 32565188Berzin TM, Parasa S, Wallace MB, Gross SA, Repici A, Sharma P. Position statement on priorities for artificial intelligence in GI endoscopy: a report by the ASGE Task Force. Gastrointest Endosc. 2020 Oct;92(4):951-959. doi: 10.1016/j.gie.2020.06.035. Epub 2020 Jun 19.
- Results publication: PubMed 36749036Mori Y, East JE, Hassan C, Halvorsen N, Berzin TM, Byrne M, von Renteln D, Hewett DG, Repici A, Ramchandani M, Al Khatry M, Kudo SE, Wang P, Yu H, Saito Y, Misawa M, Parasa S, Matsubayashi CO, Ogata H, Tajiri H, Pausawasdi N, Dekker E, Ahmad OF, Sharma P, Rex DK. Benefits and challenges in implementation of artificial intelligence in colonoscopy: World Endoscopy Organization position statement. Dig Endosc. 2023 May;35(4):422-429. doi: 10.1111/den.14531. Epub 2023 Mar 13.
- Derived from this study: PubMed 41556527Gimeno-Garcia AZ, Benitez-Zafra F, Redondo-Zaera I, Cruz-Perdomo N, Bautista M, Morales-Arraez D, Pardo-Balteiro A, Borque P, Navarro-Davila MA, Jimenez-Sosa A, Berenguer R, Tellechea J, Alayon-Miranda S, Mon J, Romero A, Alvarez L, Castillo RD, Perdomo A, Hernandez-Negrin D, Gamez S, Cedres Y, Quintana-Diaz PH, Perez-Gonzalez F, Nicolas-Perez D, Hernandez-Guerra M. An Artificial Intelligence-Guided Strategy to Reduce Poor Bowel Preparation: A Multicenter Randomized Controlled Study. Am J Gastroenterol. 2026 Apr 1;121(4):890-898. doi: 10.14309/ajg.0000000000003921. Epub 2026 Jan 20.
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.
Antonio Z Gimeno García, MD, PhD principal investigator
Hospital Universitario de Canarias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colon preparation guided by an artificial intelligence device in people with Cleansing Quality of the Colon, run by University of La Laguna at 1 site in Spain.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 4 Jun 2025. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale (time frame: 3 months). 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 NCT05871814, which also lists 4 linked publications.
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 4 Jun 2025.