NCT02785783

Brief Summary

This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the participants will receive EndoRings™ assisted colonoscopy, while the other half will receive standard colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
563

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

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

May 13, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2018

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

May 25, 2016

Last Update Submit

January 31, 2019

Conditions

Colorectal NeoplasiaIntestinal NeoplasmsDigestive NeoplasmsDigestive System DiseaseIntestinal DiseaseGastrointestinal DiseaseGastrointestinal Neoplasm

Keywords

EndoRings™

Outcome Measures

Primary Outcomes (1)

  • Number of polyps per patient

    To assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.

    14 months

Study Arms (2)

Standard colonoscopy

ACTIVE COMPARATOR

A standard colonoscope will be used to complete the procedure

Device: Standard colonoscopy

EndoRings™

ACTIVE COMPARATOR

An EndoRings™ device will be placed at the distal end of a standard colonoscope

Device: EndoRings™

Interventions

Standard colonoscopyDEVICE
Also known as: Current standard of care colonoscopy
Standard colonoscopy
EndoRings™DEVICE

Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

EndoRings™

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic patients referred for colonoscopy age ≥ 55.
  • Asymptomatic patients age ≥55 undergoing screening or surveillance for polyps and cancers.

You may not qualify if:

  • History of Inflammatory bowel disease
  • History of Hereditary non polyposis colorectal cancer (HNPCC)
  • Familial adenomatous polyposis syndrome (FAP)
  • Hyperplastic polyposis syndrome
  • Known colonic stricture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth University Hospital

Portsmouth, Hampshire, PO63LY, United Kingdom

Location

Related Publications (2)

  • van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.

    PMID: 16454841BACKGROUND

  • Dik VK, Gralnek IM, Segol O, Suissa A, Belderbos TD, Moons LM, Segev M, Domanov S, Rex DK, Siersema PD. Multicenter, randomized, tandem evaluation of EndoRings colonoscopy--results of the CLEVER study. Endoscopy. 2015 Dec;47(12):1151-8. doi: 10.1055/s-0034-1392421. Epub 2015 Jul 28.

    PMID: 26220283BACKGROUND

MeSH Terms

Conditions

Intestinal NeoplasmsDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Pradeep Bhandari, MD

    Portsmouth University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

May 30, 2016

Study Start

May 13, 2016

Primary Completion

August 7, 2018

Study Completion

August 7, 2018

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)