Detection of Adenomas in Screening Colonoscopy | NCT04651062

Studies
Detection of Adenomas in Screening Colonoscopy

NCT04651062

Sponsor

Herning Hospital

Status

Completed

Last Update Posted

Dec 3, 2020Actual

Enrollment

1,178Actual

Phase

Not Applicable

Conditions

Adenoma Colon

Interventions

endocuff
no endocuff

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Apr 1, 2020Actual

First Submitted Date

Mar 1, 2018

First Submission Date that Met QC Criteria

Nov 25, 2020

First Posted Date

Dec 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2020

Last Update Posted Date

Dec 3, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Jaensch, principan investigator, Herning HospitalPrincipal Investigator

Lead Sponsor

Herning HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used.

Detailed Description

Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope. Several minor studies have shown that the use of Endocuff probably increases the number of detected polyps in colonoscopy. Endocuff is made of soft plastic and has been designed to give an optimal view of the entire colon. It gently averts and flattens folds in order to see small polyps "hiding" in the space behind colonic folds.

The purpose of this study is to investigate into the effect of the Endocuff in screening colonoscopy compared with screening colonoscopy performed without Endocuff. The device has been used during several years yet an effect on the number of polyps detected during screenings colonoscopy has not been shown. This studies main hypothesis is that the use of Endocuff in screenings colonoscopy will increase the adenoma detection rate in these patients, with a potential to reduce interval cancer.

This study is a randomized controlled trial with 900 patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,178Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
endocuff	Experimental	all patients having performed a screeningscolonoscopy and being randomized to colonoscopy with the use of endocuff	Device: endocuff
no cuff	Active Comparator	all patients participating in a screeningscolonoscopy being randomized to colonoscopy without the use of endocuff	Procedure: no endocuff

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endocuff	Device	Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.	endocuff

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
adenoma	number of adenomas found during colonoscopy	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
cecal intubation rate	is the cecum reached during the colonoscopy	up to 2 hours
cecal intubation time	number of minutes from start procedure to cecum reached

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all Citizens participating in the national bowel screening program

Exclusion Criteria:

persons who are disabled and who do not understand the Danish language
persons treated with Marcoumar, Marevan, Eliquis, Pradaxa e.g. and who are not eligible to polyp resection
persons who due to diseases of the eyes or Heart are not allowed to receive Buscopan.
persons with active colitis/diverticulitis, colon stenosis e.g. due to cancer, where a complete colonoscopy is not possible to achieve

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kirurgisk Afdeling		Herning	Central Jutland	7400	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35141776	Derived	Jaensch C, Jepsen MH, Christiansen DH, Madsen AH, Madsen MR. Adenoma and serrated lesion detection with distal attachment in screening colonoscopy: a randomized controlled trial. Surg Endosc. 2022 Sep;36(9):1-9. doi: 10.1007/s00464-022-09049-5. Epub 2022 Feb 9.