NCT03856957

Brief Summary

Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
257

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

June 11, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

February 26, 2019

Last Update Submit

February 14, 2021

Conditions

Serrated LesionAdenomaColorectal Cancer

Keywords

Serrated LesionEndocuffDetection

Outcome Measures

Primary Outcomes (1)

  • Average number of serrated lesions ≥ 10 mm detected per colonoscopy

    Average number of serrated lesions ≥ 10 mm detected per colonoscopy

    immediate

Secondary Outcomes (9)

  • Serrated lesions detection rate

    immediate

  • Average number of serrated lesions < 10 mm detected per colonoscopy

    immediate

  • Average number of adenomas detected per colonoscopy

    immediate

  • Adenoma detection rate

    immediate

  • Adenocarcinoma detection rate

    immediate

  • +4 more secondary outcomes

Study Arms (2)

Endocuff colonoscopy

EXPERIMENTAL

Colonoscopy performed with Endocuff

Device: Endocuff colonoscopy

Conventional colonoscopy

PLACEBO COMPARATOR

Colonoscopy performed without any device

Device: control

Interventions

Endocuff colonoscopyDEVICE

Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).

Endocuff colonoscopy
controlDEVICE

colonoscopy without endocuff

Conventional colonoscopy

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Outpatients undergoing elective colonoscopies

You may not qualify if:

  • Known polyposis syndromes
  • Personal colorectal cancer history
  • Previous colorectal surgery
  • Severe diverticulosis
  • Colonic stricture
  • Inflammatory bowel disease
  • Primary sclerosing cholangitis
  • Pregnancy and breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Beatriz Ângelo

Lisbon, Loures, 2674-514, Portugal

Location

MeSH Terms

Conditions

AdenomaColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 26, 2019

First Posted

February 27, 2019

Study Start

June 11, 2018

Primary Completion

March 30, 2019

Study Completion

July 1, 2019

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

PT(1)