Status:
UNKNOWN
Capsule Endoscopy as an Alternative to Colonoscopy
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Medtronic
Conditions:
Colonic Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
704 Patients enrolled
Trial Details
Trial ID
NCT06031051
Start Date
December 22 2021
End Date
December 1 2024
Last Update
September 11 2023
Active Locations (4)
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1
Hospital universitario de Santa Cruz de Tenerife
Santa Cruz de Tenerife, Canary Islands, Spain
2
Hospital clinic of barcelona
Barcelona, Spain, 08036
3
Hospital Sant Pau
Barcelona, Spain, 08041
4
Hospital Mutua de Terrassa
Terrassa, Spain