NCT02529007

Brief Summary

The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
534

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 30, 2016

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

July 17, 2015

Last Update Submit

May 27, 2016

Conditions

Colonic PolypsColonic Neoplasms

Keywords

Colonoscopyearly cancer detectioncancer screening

Outcome Measures

Primary Outcomes (1)

  • Number of polyps detected per patient

    1 month (when pathology report available)

Secondary Outcomes (9)

  • Cancer detection rate

    1 month (when pathology report available)

  • Polyp detection rate

    1 month (when pathology report available)

  • Adenomas per patient

    1 month (when pathology report available)

  • Adenoma detection rate

    1 month (when pathology report available)

  • Caecal intubation rate

    1 day

  • +4 more secondary outcomes

Study Arms (2)

Standard

ACTIVE COMPARATOR

These patients have standard colonoscopy performed

Other: Standard colonoscopy

Endocuff

EXPERIMENTAL

These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope

Device: Endo-cuff

Interventions

Endo-cuffDEVICE

Colonoscopy performed with endo-cuff attached to the colonoscope

Endocuff
Standard colonoscopyOTHER

Standard colonoscopy without end-cuff

Standard

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for colonoscopy under the national bowel cancer screening programme
  • Able to provide written informed consent

You may not qualify if:

  • History of Inflammatory bowel disease
  • History of Hereditary non polyposis colorectal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Publications (1)

  • Bhattacharyya R, Chedgy F, Kandiah K, Fogg C, Higgins B, Haysom-Newport B, Gadeke L, Thursby-Pelham F, Ellis R, Goggin P, Longcroft-Wheaton G, Bhandari P. Endocuff-assisted vs. standard colonoscopy in the fecal occult blood test-based UK Bowel Cancer Screening Programme (E-cap study): a randomized trial. Endoscopy. 2017 Nov;49(11):1043-1050. doi: 10.1055/s-0043-111718. Epub 2017 Jun 14.

    PMID: 28614895DERIVED

MeSH Terms

Conditions

Colonic PolypsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Pradeep Bhandari, MBBS, MD, MRCP

    Portsmouth Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 17, 2015

First Posted

August 19, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 30, 2016

Record last verified: 2015-07

Locations

GB(1)