Colonic DiseaseCAPSUCOVIDNCT06031051
Capsule Endoscopy as an Alternative to Colonoscopy
A study testing Pillcam Crohn's Capsule Endoscopy in people with Colonic Disease, run by Hospital Clinic of Barcelona at 4 sites in Spain.
Trial summary
This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Disease
- What is being tested?
- Pillcam Crohn's Capsule Endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 704 participants
- Where
- 4 sitesSpain
- Study dates
- 22 Dec 2021to Dec 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
- Iron deficiency anaemia with or without a colonoscopy performed within the last 5 years
- Rectal bleeding/haematochezia in patients >50 years who have undergone a colonoscopy <5 years ago or <50 years with no risk factors for CRC
- Chronic constipation/abdominal distension/abdominal pain/diarrhea
- Suspected CRC due to clinical criteria (NICE guidelines 2015, updated in 2017) with no iFOBT performed
- Recent change in bowel habits
- Follow-ups: post-polypectomy syndrome, family history of CRC, hereditary syndromes, CRC surgery, Inflammatory Bowel Disease
Who cannot join
- Study following an episode of complicated acute diverticulitis or with an uncertain diagnosis of acute diverticulitis
- Evaluation following fragmented resection (recurrence ruled out)
- Patients with a positive FIT
- Pregnancy or breast-feeding
- Any contraindication to Crohn's Capsule endoscopy such as known or suspected gastrointestinal obstruction, strictures or fistulas, a previous altered Patency capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other implanted electromedical devices.
- Allergy or known contraindication to the medications and preparations agents used in the procedure.
Trial locations and contacts
4 sites in 1 country.
Miguel Urpí Ferreruela, MD contact
Spain4 sites, 4 recruiting
- Recruiting
Hospital clinic of barcelona
Barcelona, 08036
BEGOÑA GONZALEZ SUAREZ, +34661334362, bgonzals@clinic.cat
- Recruiting
Hospital Sant Pau
Barcelona, 08041
Cristina Romero Mascarell, MD, cromerom@santpau.cat
- Recruiting
Hospital universitario de Santa Cruz de Tenerife
Santa Cruz de Tenerife, Canary Islands
Antonio Zebenzuy Gimeno-García, antozeben@gmail.com
- Recruiting
Hospital Mutua de Terrassa
Terrassa
Montserrat Aceituno Quintanilla, maceituno@mutuaterrassa.es
About this study
Official title: Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?
This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.
Read the detailed description
Study design Enrolled patients already scheduled for non-urgent colonoscopy according to local practice will be offered to undergo an early CE; in case of negative proof they will perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive findings, requiring endoscopic treatment or intervention, colonoscopy will be performed within 30 days from CE (early colonoscopy).
Study population Patients who received the indication for colonoscopy as per clinical practice and subsequently identified as non-urgent procedures, according to locally established prioritization criteria
- Conditions
- Colonic Disease
- Being tested
- Pillcam Crohn's Capsule Endoscopy
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pillcam Crohn's Capsule EndoscopyDevice
Also called Pillcam
Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Pillcam Crohn's Capsule Endoscopy and colonoscopy | Other | All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy Receives: Device: Pillcam Crohn's Capsule Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients who could avoid colonoscopy
To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE
Measured: 6 months
Secondary outcomes (2)
CE diagnostic yield and adenoma detection rate (ADR)
Number of adenoma detected by CE
Measured: 6 months
To compare CE and CC findings
Compare findings between both techniques
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start22 Dec 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 704 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Begoña González Suárez, Hospital Clinic of Barcelona
- Investigators
- BEGOÑA GONZALEZ SUAREZ, MD PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031051
- Sponsor's protocol ID
- CAPSUCOVID
- Acronym
- CAPSUCOVID
- Status last verified
- Sep 2023
- First submitted
- 1 Mar 2023
- Last updated
- 11 Sep 2023
- 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?
- ClinicalTrials.gov ID
- NCT06031051
- Acronym / sponsor ID
- CAPSUCOVID / CAPSUCOVID
- Conditions
- Colonic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 704 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Sep 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.
This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.
Detailed description
Study design Enrolled patients already scheduled for non-urgent colonoscopy according to local practice will be offered to undergo an early CE; in case of negative proof they will perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive findings, requiring endoscopic treatment or intervention, colonoscopy will be performed within 30 days from CE (early colonoscopy).
Study population Patients who received the indication for colonoscopy as per clinical practice and subsequently identified as non-urgent procedures, according to locally established prioritization criteria
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pillcam Crohn's Capsule Endoscopy and colonoscopy | Other | Device: Pillcam Crohn's Capsule EndoscopyAll patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Iron deficiency anaemia with or without a colonoscopy performed within the last 5 years
Key exclusion criteria (6 listed)
- Study following an episode of complicated acute diverticulitis or with an uncertain diagnosis of acute diverticulitis
- Evaluation following fragmented resection (recurrence ruled out)
- Patients with a positive FIT
- Pregnancy or breast-feeding
- Any contraindication to Crohn's Capsule endoscopy such as known or suspected gastrointestinal obstruction, strictures or fistulas, a previous altered Patency capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other implanted electromedical devices.
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 |
|---|---|---|
| Pillcam Crohn's Capsule EndoscopyAlso: PillcamPatients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy | Device | Pillcam Crohn's Capsule Endoscopy and colonoscopy |
Primary outcome
percentage of patients who could avoid colonoscopy
Time frame: 6 months
To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE
2 secondary outcomes
CE diagnostic yield and adenoma detection rate (ADR)
Time frame: 6 months
To compare CE and CC findings
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Colonic Disease
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
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.
Miguel Urpí Ferreruela, MD contact
BEGOÑA GONZALEZ SUAREZ, MD PhD principal investigator
Hospital Clinic of Barcelona
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pillcam Crohn's Capsule Endoscopy in people with Colonic Disease, run by Hospital Clinic of Barcelona at 4 sites 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 6 inclusion and 6 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 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BEGOÑA GONZALEZ SUAREZ, MD, PhD (+34661334362, bgonzals@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients who could avoid colonoscopy (time frame: 6 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 11 Sep 2023.