NCT02374515

Brief Summary

This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy. Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

February 23, 2015

Last Update Submit

June 13, 2016

Conditions

Adenomatous Polyps

Outcome Measures

Primary Outcomes (1)

  • adenoma detection rate

    20 min.

Study Arms (2)

Endocuff assisted Colonoscopy

ACTIVE COMPARATOR

Endocuff assisted Colonoscopy

Device: EndoCuff-assisted colonoscopy

Standard Colonoscopy

ACTIVE COMPARATOR

Standard colonoscopy

Device: Standard Colonoscopy

Interventions

EndoCuff-assisted colonoscopyDEVICE

Adenoma detection rate

Also known as: EC-assisted colonoscopy
Endocuff assisted Colonoscopy
Standard ColonoscopyDEVICE
Standard Colonoscopy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colonoscopy: Screening , Surveillance, Diagnostic

You may not qualify if:

  • Pregnancy
  • age\<18 years
  • age \> 80 years
  • known colonic strictures
  • chronic inflammatory bowel disease
  • active inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Adenomatous Polyps

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Giovanni D. De Palma, MD

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Surgery

Study Record Dates

First Submitted

February 23, 2015

First Posted

February 27, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 15, 2016

Record last verified: 2016-06

Locations

IT(1)