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Capsule Endoscopy as an Alternative to Colonoscopy (CAPSUCOVID)

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ClinicalTrials.gov Identifier: NCT06031051
Recruitment Status : Recruiting
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Begoña González Suárez, Hospital Clinic of Barcelona

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colonic Disease Device: Pillcam Crohn's Capsule Endoscopy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 704 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?
Actual Study Start Date : December 22, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Pillcam Crohn's Capsule Endoscopy and colonoscopy
All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy
 Device: Pillcam Crohn's Capsule Endoscopy
Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy
Other Name: Pillcam


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. CE diagnostic yield and adenoma detection rate (ADR) [ Time Frame: 6 months ]
    Number of adenoma detected by CE

  2. To compare CE and CC findings [ Time Frame: 6 months ]
    Compare findings between both techniques


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031051


Contacts
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Contact: BEGOÑA GONZALEZ SUAREZ, MD, PhD +34661334362 bgonzals@clinic.cat
Contact: Miguel Urpí Ferreruela, MD murpi@recerca.clinic.cat

Locations
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Spain
Hospital universitario de Santa Cruz de Tenerife Recruiting
Santa Cruz De Tenerife, Canarias, Spain
Contact: Antonio Zebenzuy Gimeno-García       antozeben@gmail.com   
Hospital clinic of barcelona Recruiting
Barcelona, Spain, 08036
Contact: BEGOÑA GONZALEZ SUAREZ    +34661334362    bgonzals@clinic.cat   
Hospital Sant Pau Recruiting
Barcelona, Spain, 08041
Contact: Cristina Romero Mascarell, MD       cromerom@santpau.cat   
Hospital Mutua de Terrassa Recruiting
Terrassa, Spain
Contact: Montserrat Aceituno Quintanilla       maceituno@mutuaterrassa.es   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Medtronic
Investigators
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Principal Investigator: BEGOÑA GONZALEZ SUAREZ, MD PhD Hospital Clinic of Barcelona
More Information
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Responsible Party: Begoña González Suárez, MD PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT06031051    
Other Study ID Numbers: CAPSUCOVID
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases