Adenoma Detection Rate in Colonoscopy Performed With Endo... | NCT03219918

Studies
Adenoma Detection Rate in Colonoscopy Performed With EndoRings

NCT03219918

Sponsor

Zealand University Hospital

Status

Terminated

Last Update Posted

Apr 11, 2019Actual

Enrollment

97Actual

Phase

Not Applicable

Conditions

Colorectal Adenoma
Colorectal Neoplasms

Interventions

EndoRings II Distal Attachment

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Practically difficult to inroll the number of patients anticipated

Expanded Access Info

Start Date

Jun 19, 2017Actual

Primary Completion Date

Jun 7, 2018Actual

Completion Date

Jun 7, 2018Actual

First Submitted Date

Jun 13, 2017

First Submission Date that Met QC Criteria

Jul 13, 2017

First Posted Date

Jul 18, 2017Actual

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

Apr 9, 2019

Last Update Posted Date

Apr 11, 2019Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is designed to examine whether colonoscopy using an EndoRings cap has a higher adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare completion rate, completion time, complication rate and detection of malignancies. Half of the patients will be randomised to colonoscopy using cap and the other half to no cap.

Detailed Description

Colonoscopy is recognised as the standard method for finding and removing colorectal adenomas, which are precursors of most colorectal cancers. It has been shown that there is a direct correlation between adenoma detection rate and the risk of developing colorectal cancer subsequently. However, patients undergoing colonoscopy are still at risk of developing colorectal cancer, mainly because precursor lesions are missed during the procedure. This may be due to insufficient bowel preparation, difficulties in visualising flat lesions or the location of lesions behind haustral folds.

Improving the ADR can be achieved by different means; better training of endoscopists, improved bowel preparation, optimal sedation and medico technical developments. The technical improvements have mainly been in the optimising of image and improved scope thickness and flexibility, including devices that improve visualisation by increasing the exposed colonic surface . One of these new inventions is the EndoRings II Distal Attachment.

According to the Danish Colorectal Cancer Screening Database, the ADR of standard screening colonoscopy is between 34 and 67 % with a national average of 49 % of patients with detected adenomas. Due to the known adenoma miss rate in standard screening colonoscopies, it is important to increase the ADR on average as well as finding ways to improve ADR for centres with a lower than average ADR.

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

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With EndoRings	Active Comparator	Colonoscopy is performed with the use of the cap-device EndoRings II Distal Attachment to be attached to the tip of the colonoscope	Device: EndoRings II Distal Attachment
NO EndoRings	No Intervention	Colonoscopy is performed conventionally without any caps

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EndoRings II Distal Attachment	Device	Colonoscopy cap	With EndoRings

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adenoma detection rate	Number of colorectal adenomas/neoplasms/carcinomas found in colonoscopy	maximum 60 minutes

Secondary Outcomes

Measure	Description	Time Frame
Completion time	Overall colonoscopy duration	maximum 60 minutes
Completion rate	Colonoscopy completion (intubation to coecum)	maximum 60 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients meeting all the below listed criteria are eligible for inclusion in the trial:

Age between 50 - 74 years (age range of screening population)
Positive HemoCult home test from the Danish Colorectal Cancer Screening Programme
Ability to give informed consent to participation in the trial.

Exclusion Criteria:

Patients meeting one or more of the below listed criteria will be excluded from the trial:

History of colorectal cancer
History of Inflammatory Bowel Disease
Part of other control programme (e.g. HNPCC or adenoma control)
ASA =/> 4 and/or necessity of general anaesthesia
Former surgery with removal of a part of the colon on either benign or malignant background

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Line E Line, MD	Zealand University Hospital Køge	Principal Investigator
Ismayil Gögenur, Prof, DMSc	Zealand University Hospital Køge	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zealand University Hospital Køge, Department of Surgery		Køge		4600	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D056587	Cryopyrin-Associated Periodic Syndromes

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

The study is a single-centre prospective randomised clinical trial. Patients are included if they meet the specified inclusion criteria and accept to take part in the study after proper oral and written information (see patient information below).

Specimens i.e. removed adenomas and biopsies of suspected malignancies are analysed by pathologists according to standard procedure. The pathologist will not know the nature of specimen collection (colonoscopy with or without EndoRings). The specimens are not saved for any other study related activities.

Masking Info

Masking

Double

Masking Description

It is partially blinded in the way that the endoscopist knows whether the procedure is performed with or without the EndoRings but neither patient, pathologist nor investigators will have this information, which is only to be revealed to the investigators at the end of data processing.

Who Masked

InvestigatorOutcomes Assessor