EndoRings Colonoscopy for Adenoma Detection | NCT03469622

Studies
EndoRings Colonoscopy for Adenoma Detection

NCT03469622

Sponsor

Helios Albert-Schweitzer-Klinik Northeim

Status

Unknown status

Last Update Posted

Feb 12, 2019Actual

Enrollment

225Estimated

Phase

Not Applicable

Conditions

Adenoma

Interventions

EndoRings
Standard colonoscopy

Countries

Germany

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2018Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Mar 6, 2018

First Submission Date that Met QC Criteria

Mar 16, 2018

First Posted Date

Mar 19, 2018Actual

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

Feb 10, 2019

Last Update Posted Date

Feb 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.

EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal

Detailed Description

Not provided

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

225Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EndoRings	Active Comparator	Colonoscopy is performed with the EndoRings attached	Device: EndoRings
Standard Colonoscopy	Active Comparator	Standard colonoscopy without any additional devices	Device: Standard colonoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EndoRings	Device	EndoRings-assisted colonoscopy	EndoRings
Standard colonoscopy

Measure	Description	Time Frame
Adenoma detection rate		during colonoscopy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

indication for colonoscopy (screening, surveillance, diagnostic)
age ≥ 45 years
ability to give informed consent

Exclusion Criteria:

pregnancy
age <45 years
known colonic strictures
chronic inflammatory bowel disease
active inflammation
s/p colonic resection
bleeding disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tobias Meister, Prof. Dr.	Contact	+495551971244		tobias.meister@helios-gesundheit.de

Overall Officials

Name	Affiliation	Role
Tobias Meister, Prof. Dr.	HELIOS Albert-Schweitzer Klinik	Principal Investigator
Ralf Kiesslich, Prof. Dr.	HELIOS HSK Kliniken Wiesbaden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HELIOS HSK Kliniken	Recruiting	Wiesbaden	Hesse	65199	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000236	Adenoma
D011127	Polyps

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020763	Pathological Conditions, Anatomical

Browse Leaves

Not provided

Browse Branches

Not provided