Capsule Endoscopy as an Alternative to Colonoscopy

Colonic Disease Clinical Trial

— CAPSUCOVID  

Official title:

Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031051
• Other study ID #: CAPSUCOVID
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Hospital Clinic of Barcelona
• Contact: BEGOÑA GONZALEZ SUAREZ, MD, PhD
• Phone: +34661334362
• Email: bgonzals[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 704
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases

Intervention

Device:
• Pillcam Crohn's Capsule Endoscopy
Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy

Locations

Country	Name	City	State
Spain	Hospital clinic of barcelona	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	Hospital universitario de Santa Cruz de Tenerife	Santa Cruz De Tenerife	Canarias
Spain	Hospital Mutua de Terrassa	Terrassa

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Medtronic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients who could avoid colonoscopy	To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE	6 months
Secondary	CE diagnostic yield and adenoma detection rate (ADR)	Number of adenoma detected by CE	6 months
Secondary	To compare CE and CC findings	Compare findings between both techniques	6 months