NCT06031051

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
704

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

March 1, 2023

Last Update Submit

September 1, 2023

Conditions

Colonic Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • CE diagnostic yield and adenoma detection rate (ADR)

    6 months

  • To compare CE and CC findings

    6 months

Study Arms (1)

Pillcam Crohn's Capsule Endoscopy and colonoscopy

OTHER

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

Device: Pillcam Crohn's Capsule Endoscopy

Interventions

Pillcam Crohn's Capsule EndoscopyDEVICE

Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy

Also known as: Pillcam
Pillcam Crohn's Capsule Endoscopy and colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital universitario de Santa Cruz de Tenerife

Santa Cruz de Tenerife, Canary Islands, Spain

RECRUITING

Hospital clinic of barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Mutua de Terrassa

Terrassa, Spain

RECRUITING

MeSH Terms

Conditions

Colonic Diseases

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • BEGOÑA GONZALEZ SUAREZ, MD PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BEGOÑA GONZALEZ SUAREZ, MD, PhD

CONTACT

+34661334362bgonzals@clinic.cat

Miguel Urpí Ferreruela, MD

CONTACT

murpi@recerca.clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 1, 2023

First Posted

September 11, 2023

Study Start

December 22, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)