NCT02340065

Brief Summary

The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible additive contribution in the detection of important lesions, namely polyps and cancers, compared to standard colonoscopy, in a series of patients undergoing back-to-back screening or surveillance colonoscopies in a randomized fashion. Moreover, we aim to assess possible changes regarding post-polypectomy surveillance programs following Endocuff utilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 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

January 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

January 13, 2015

Last Update Submit

July 13, 2016

Conditions

Colon Neoplasms

Keywords

colonoscopyadenoma detection rateEndocuff-assisted colonoscopy

Outcome Measures

Primary Outcomes (1)

  • number and rate of missed adenomas

    in the entire colon

    one week

Secondary Outcomes (9)

  • number of adenomas and adenoma detection rate in the entire colon

    one week

  • number of adenomas and adenoma detection rate in the right colon

    one week

  • number of polyps and polyp detection rate in the entire colon

    one week

  • number of polyps and polyp detection rate in the right colon

    one week

  • colonoscopy completion (colonoscopy completion rate, reason for incomplete colonoscopy)

    one week

  • +4 more secondary outcomes

Study Arms (2)

standard colonoscopy

ACTIVE COMPARATOR

total polyp/adenoma detection with standard colonoscopy, polyp/adenoma detection in the right colon with standard colonoscopy

Procedure: Endocuff-assisted colonoscopy

Endocuff-assisted colonoscopy

ACTIVE COMPARATOR

total polyp/adenoma detection with Endocuff-assisted colonoscopy, polyp/adenoma detection in the right colon with Endocuff-assisted colonoscopy

Procedure: standard colonoscopy

Interventions

standard colonoscopyPROCEDURE

examination of the colon with a conventional colonoscope

Also known as: conventional colonoscopy
Endocuff-assisted colonoscopy
Endocuff-assisted colonoscopyPROCEDURE

examination of the colon with Endocuff-assisted colonoscopy

Also known as: Endocuff
standard colonoscopy

Eligibility Criteria

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

You may qualify if:

  • adults undergoing elective screening or surveillance colonoscopy
  • symptomatic adults with indication for colonoscopy

You may not qualify if:

  • age\<18 and \> 80 years
  • poor overall health (ASA III, IV)
  • recent abdominal surgery
  • presence of abdominal wall hernias
  • active colitis
  • previous bowel resection
  • inflammatory bowel disease
  • polyposis syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital

Haidari, Attica, 12462, Greece

Location

Related Publications (3)

  • Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.

    PMID: 25470133BACKGROUND

  • Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166.

    PMID: 24921209BACKGROUND

  • Triantafyllou K, Polymeros D, Apostolopoulos P, Lopes Brandao C, Gkolfakis P, Repici A, Papanikolaou IS, Dinis-Ribeiro M, Alexandrakis G, Hassan C. Endocuff-assisted colonoscopy is associated with a lower adenoma miss rate: a multicenter randomized tandem study. Endoscopy. 2017 Nov;49(11):1051-1060. doi: 10.1055/s-0043-114412. Epub 2017 Aug 1.

    PMID: 28763808DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • KONSTANTINOS TRIANTAFYLLOU, PROF

    Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece

    STUDY CHAIR

  • DIMITRIOS POLYMEROS, MD

    Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

GR(1)