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Capsule Endoscopy as an Alternative to Colonoscopy (CAPSUCOVID)

Primary Purpose

Colonic Disease

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pillcam Crohn's Capsule Endoscopy
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital universitario de Santa Cruz de TenerifeRecruiting
  • Hospital clinic of barcelonaRecruiting
  • Hospital Sant PauRecruiting
  • Hospital Mutua de TerrassaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pillcam Crohn's Capsule Endoscopy and colonoscopy

Arm Description

All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy

Outcomes

Primary Outcome Measures

percentage of patients who could avoid colonoscopy
To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE

Secondary Outcome Measures

CE diagnostic yield and adenoma detection rate (ADR)
Number of adenoma detected by CE
To compare CE and CC findings
Compare findings between both techniques

Full Information

First Posted
March 1, 2023
Last Updated
September 1, 2023
Sponsor
Hospital Clinic of Barcelona
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT06031051
Brief Title
Capsule Endoscopy as an Alternative to Colonoscopy
Acronym
CAPSUCOVID
Official Title
Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
704 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pillcam Crohn's Capsule Endoscopy and colonoscopy
Arm Type
Other
Arm Description
All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy
Intervention Type
Device
Intervention Name(s)
Pillcam Crohn's Capsule Endoscopy
Other Intervention Name(s)
Pillcam
Intervention Description
Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy
Primary Outcome Measure Information:
Title
percentage of patients who could avoid colonoscopy
Description
To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE
Time Frame
6 months
Secondary Outcome Measure Information:
Title
CE diagnostic yield and adenoma detection rate (ADR)
Description
Number of adenoma detected by CE
Time Frame
6 months
Title
To compare CE and CC findings
Description
Compare findings between both techniques
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BEGOÑA GONZALEZ SUAREZ, MD, PhD
Phone
+34661334362
Email
bgonzals@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Urpí Ferreruela, MD
Email
murpi@recerca.clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BEGOÑA GONZALEZ SUAREZ, MD PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital universitario de Santa Cruz de Tenerife
City
Santa Cruz De Tenerife
State/Province
Canarias
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Zebenzuy Gimeno-García
Email
antozeben@gmail.com
Facility Name
Hospital clinic of barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BEGOÑA GONZALEZ SUAREZ
Phone
+34661334362
Email
bgonzals@clinic.cat
Facility Name
Hospital Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Romero Mascarell, MD
Email
cromerom@santpau.cat
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montserrat Aceituno Quintanilla
Email
maceituno@mutuaterrassa.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Capsule Endoscopy as an Alternative to Colonoscopy

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