Outpatient ColonoscopyCOLObsNCT06916052
Study to Analyse the Use of a Digital Platform for the Preparation and Follow-up of Patients With Scheduled Outpatients Colonoscopy
An observational study of Outpatient Colonoscopy, run by Persei Vivarium at 1 site in Spain.
Trial summary
The goal of this clinical trial investigation with device is to to analyze the use of the Caaring® digital platform for the preparation and follow-up of scheduled colonoscopy. Colonoscopy is a difficult procedure, and it is estimated that bowel preparation is inadequate in about 25% of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Outpatient Colonoscopy
- How many people
- 225 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2025to Aug 2025
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients from the Hospital Clínic in Barcelona diagnosed with a scheduled colonoscopy who meet the selection criteria and sign the informed consent will be included.
Who may be able to join
- Age 18 or older.
- Signed informed consent.
- Patients scheduled for outpatient colonoscopy.
- Patients able to complete the study questionnaires.
- Patients who regularly use a smartphone
Who cannot join
- Patients enrolled in the population-based colorectal cancer screening program with a positive fecal occult blood test.
- Minors or elderly patients (over 80 years of age).
- Patients with prior colorectal surgery.
- Patients who, in the opinion of the researcher, will not be able to commit to follow-up or lack adequate technological skills.
- Inability to provide adequate informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Francesc Balaguer Prunés, PhD, +34932275400, fprunes@clinic.cat
About this study
Official title: An Observational Study of the Digital Platform Use for the Preparation and Monitoring of Patients With Scheduled Outpatient Colonoscopy
The goal of this clinical trial investigation with device is to to analyze the use of the Caaring® digital platform for the preparation and follow-up of scheduled colonoscopy.
Colonoscopy is a difficult procedure, and it is estimated that bowel preparation is inadequate in about 25% of patients. The main question it aims to answer is if the use of a digital platform (Caaring®) could be an effective tool for reducing the percentage of inadequate bowel preparations in patients with a scheduled colonoscopy. To this end, the application will provide precise instructions to patients.
Read more
A prospective, single-center, observational study with software device: The recruitment phase is expected to last two months. Patients will be followed for one month after the colonoscopy and 14 days prior to it.
Additionally, measuring patient experience and monitoring adverse effects after a colonoscopy are crucial to improving the safety of colonoscopies and the quality of healthcare, promoting higher quality colonoscopy services.
For that to happen, participants must have sufficient technological skills to use a smartphone.
Read the detailed description
A prospective, single-center, observational study with software device. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki.
- Conditions
- Outpatient Colonoscopy
- Keywords
- Colonoscopy preparation, Digital Platform, Caaring, Outpatient colonoscopy, DTx, Patient-reported Data, Real World Data, RWD, PROMs, Digital Health
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients scheduled colonoscopy who have an adequate bowel preparation.
Percentage of colonoscopies with adequate bowel preparation defined as having a total Boston Bowel Preparation Scale (BBPS) score greater than or equal of 6 and BBPS score for per colon segment ≥2.
Measured: Day 0, (Colonoscopy Day)
Secondary outcomes (16)
Active Patient Rate
Active patient rate defined as the number of patients who activate their account divided by the total number of patients guests.
Measured: Day -14 (14 days before the colonoscopy)
Patients with section completed: Treatments
Of active patients, percentage who completes the section Treatments
Measured: Day -14 (14 days before the colonoscopy)
Patients with section completed: Pick up the bowel preparation
Of active patients, percentage who completes the section Pick up the bowel preparation.
Measured: Day -10 (10 days before colonoscopy)
Patients with section completed: Colonoscopy Preparation Solution (laxative).
Of active patients, percentage who completes the secion Colonoscopy Preparation Solution (laxative).
Measured: Day 2 (2 days after colonoscopy)
Patients with section completed: Procedure satisfaction questionnaire
Of active patients, percentage who completed the section Procedure satisfaction questionnaire.
Measured: Day 3 (3 days after colonoscopy)
Patients with section completed: Adverse Events
Of active patients, percentage of patients who completes the Adverse Events section.
Measured: Day 1, Day 14 and Day 30
Percentage of patients with 100% of data completed
Percentage of patients with 100% of data completed in the application.
Measured: Day 31 (31days after the colonoscopy)
Patients who view educational materials: Pick up the laxative
Of active patients, percentage of Patients who view the educational materials: Pick up the laxative. The app will reflect the date and time that patients viewed that information.
Measured: Day -10 (10 days before colonoscopy)
Patients who view educational materials: Diet
Of active patients, percentage of Patients who view the educational material: Diet. The app will reflect the date and time that patients viewed that information.
Measured: Day -4 (4 days before colonoscopy)
Patients who view educational materials: Adequate preparation for a colonoscopy
Of active patients, percentage of Patients who view the educational material: Adequate preparation for a colonoscopy . The app will reflect the date and time that patients viewed that information.
Measured: Day -4 (4 days before colonoscopy)
Patients who view educational materials: Bring someone
Of active patients, percentage of Patients who view the educational material: bring someone. The app will reflect the date and time that patients viewed that information.
Measured: Day -4 (4 days before colonoscopy)
Patients who view educational materials: Instructions for your colonoscopy
Of active patients, percentage of Patients who view the educational material: Instructions for your colonoscopy. The app will reflect the date and time that patients viewed that information.
Measured: Day -3 (3 days before colonoscopy)
Percentage of patients with 100% of education materials viewed.
Percentage of patients with 100% of educational materials viewed in the application.
Measured: Day 31 (31days after the colonoscopy)
Percentage of patients who take the laxative
Percentage of patients who take the laxative.
Measured: Day -3 (3 days before the colonoscopy)
Patient satisfaction with the bowel preparation (laxative)
The patient satisfaction with the bowel preparation will be measured through a specific satisfaction questionnaire created for this purpose. (Value 1-4). A higher score reflects greater satisfaction with software care.
Measured: Day 2 (2 days after colonoscopy)
Patient satisfaction with the colonoscopy experience
The patient satisfaction with the colonoscopy experience will be measured through a specific satisfaction questionnaire created for this purpose. (Value 1-5). A higher score reflects greater satisfaction with software care.
Measured: Day 3 (3 days after colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start13 Mar 2025
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outpatient ColonoscopyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Persei Vivarium
- Sponsor type
- University, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916052
- Sponsor's protocol ID
- COLObs
- Acronym
- COLObs
- Status last verified
- Jun 2025
- First submitted
- 31 Mar 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Digital Platform Use for the Preparation and Monitoring of Patients With Scheduled Outpatient Colonoscopy
- ClinicalTrials.gov ID
- NCT06916052
- Acronym / sponsor ID
- COLObs / COLObs
- Conditions
- Outpatient Colonoscopy
- Keywords
- Colonoscopy preparation, Digital Platform, Caaring, Outpatient colonoscopy, DTx, Patient-reported Data, Real World Data, RWD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Persei VivariumUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 8 Apr 2025 (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 goal of this clinical trial investigation with device is to to analyze the use of the Caaring® digital platform for the preparation and follow-up of scheduled colonoscopy.
Colonoscopy is a difficult procedure, and it is estimated that bowel preparation is inadequate in about 25% of patients. The main question it aims to answer is if the use of a digital platform (Caaring®) could be an effective tool for reducing the percentage of inadequate bowel preparations in patients with a scheduled colonoscopy. To this end, the application will provide precise instructions to patients.
A prospective, single-center, observational study with software device: The recruitment phase is expected to last two months. Patients will be followed for one month after the colonoscopy and 14 days prior to it.
Additionally, measuring patient experience and monitoring adverse effects after a colonoscopy are crucial to improving the safety of colonoscopies and the quality of healthcare, promoting higher quality colonoscopy services.
For that to happen, participants must have sufficient technological skills to use a smartphone.
Detailed description
A prospective, single-center, observational study with software device. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients from the Hospital Clínic in Barcelona diagnosed with a scheduled colonoscopy who meet the selection criteria and sign the informed consent will be included.
Key inclusion criteria (5 listed)
- Age 18 or older.
- Signed informed consent.
- Patients scheduled for outpatient colonoscopy.
- Patients able to complete the study questionnaires.
- Patients who regularly use a smartphone
Key exclusion criteria (5 listed)
- Patients enrolled in the population-based colorectal cancer screening program with a positive fecal occult blood test.
- Minors or elderly patients (over 80 years of age).
- Patients with prior colorectal surgery.
- Patients who, in the opinion of the researcher, will not be able to commit to follow-up or lack adequate technological skills.
- Inability to provide adequate informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients scheduled colonoscopy who have an adequate bowel preparation.
Time frame: Day 0, (Colonoscopy Day)
Percentage of colonoscopies with adequate bowel preparation defined as having a total Boston Bowel Preparation Scale (BBPS) score greater than or equal of 6 and BBPS score for per colon segment ≥2.
16 secondary outcomes
Active Patient Rate
Time frame: Day -14 (14 days before the colonoscopy)
Patients with section completed: Treatments
Time frame: Day -14 (14 days before the colonoscopy)
Patients with section completed: Pick up the bowel preparation
Time frame: Day -10 (10 days before colonoscopy)
Patients with section completed: Colonoscopy Preparation Solution (laxative).
Time frame: Day 2 (2 days after colonoscopy)
Patients with section completed: Procedure satisfaction questionnaire
Time frame: Day 3 (3 days after colonoscopy)
Patients with section completed: Adverse Events
Time frame: Day 1, Day 14 and Day 30
Percentage of patients with 100% of data completed
Time frame: Day 31 (31days after the colonoscopy)
Patients who view educational materials: Pick up the laxative
Time frame: Day -10 (10 days before colonoscopy)
Patients who view educational materials: Diet
Time frame: Day -4 (4 days before colonoscopy)
Patients who view educational materials: Adequate preparation for a colonoscopy
Time frame: Day -4 (4 days before colonoscopy)
Patients who view educational materials: Bring someone
Time frame: Day -4 (4 days before colonoscopy)
Patients who view educational materials: Instructions for your colonoscopy
Time frame: Day -3 (3 days before colonoscopy)
Percentage of patients with 100% of education materials viewed.
Time frame: Day 31 (31days after the colonoscopy)
Percentage of patients who take the laxative
Time frame: Day -3 (3 days before the colonoscopy)
Patient satisfaction with the bowel preparation (laxative)
Time frame: Day 2 (2 days after colonoscopy)
Patient satisfaction with the colonoscopy experience
Time frame: Day 3 (3 days after colonoscopy)
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 15 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outpatient Colonoscopy, run by Persei Vivarium 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 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?
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?
Contact Roberto Bravo (+34 915004013, roberto.bravo@perseivivarium.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients scheduled colonoscopy who have an adequate bowel preparation. (time frame: Day 0, (Colonoscopy Day)). 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 15 Jun 2025.