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EndoRings Colonoscopy for Adenoma Detection (ER)

Primary Purpose

Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
EndoRings
Standard colonoscopy
Sponsored by
Helios Albert-Schweitzer-Klinik Northeim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma focused on measuring Adenoma, Polyp, EndoRings, Colonoscopy, Endoscopic device, Colon cancer screening

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HELIOS HSK KlinikenRecruiting
  • Department of Gastroenterology, University Medical CenterRecruiting
  • HELIOS St. Marienberg Klinik HelmstedtRecruiting
  • Helios Albert-Schweitzer-Hospital, Academic University Teaching HospitalRecruiting
  • HELIOS Medical Center SiegburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EndoRings

Standard Colonoscopy

Arm Description

Colonoscopy is performed with the EndoRings attached

Standard colonoscopy without any additional devices

Outcomes

Primary Outcome Measures

Adenoma detection rate

Secondary Outcome Measures

Full Information

First Posted
March 6, 2018
Last Updated
February 10, 2019
Sponsor
Helios Albert-Schweitzer-Klinik Northeim
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1. Study Identification

Unique Protocol Identification Number
NCT03469622
Brief Title
EndoRings Colonoscopy for Adenoma Detection
Acronym
ER
Official Title
EndoRings Versus Standard Colonoscopy for Adenoma Detection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helios Albert-Schweitzer-Klinik Northeim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
Keywords
Adenoma, Polyp, EndoRings, Colonoscopy, Endoscopic device, Colon cancer screening

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EndoRings
Arm Type
Active Comparator
Arm Description
Colonoscopy is performed with the EndoRings attached
Arm Title
Standard Colonoscopy
Arm Type
Active Comparator
Arm Description
Standard colonoscopy without any additional devices
Intervention Type
Device
Intervention Name(s)
EndoRings
Intervention Description
EndoRings-assisted colonoscopy
Intervention Type
Device
Intervention Name(s)
Standard colonoscopy
Intervention Description
Standard colonoscopy without any additional devices
Primary Outcome Measure Information:
Title
Adenoma detection rate
Time Frame
during colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Meister, Prof. Dr.
Phone
+495551971244
Email
tobias.meister@helios-gesundheit.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Meister, Prof. Dr.
Organizational Affiliation
HELIOS Albert-Schweitzer Klinik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ralf Kiesslich, Prof. Dr.
Organizational Affiliation
HELIOS HSK Kliniken Wiesbaden
Official's Role
Principal Investigator
Facility Information:
Facility Name
HELIOS HSK Kliniken
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65199
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf Kiesslich, Prof. Dr.
Phone
+49611432420
Email
ralf.kiesslich@helios-gesundheit.de
Facility Name
Department of Gastroenterology, University Medical Center
City
Göttingen
State/Province
Lower Saxony
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Ellenrieder, Professor
Phone
+49551390
Email
Volker.Ellenrieder@med.uni-goettingen.de
Facility Name
HELIOS St. Marienberg Klinik Helmstedt
City
Helmstedt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Detlev Ameis, Prof.Dr.med.
Phone
0049 53 51 14 - 0
Email
detlev.ameis@helios-kliniken.de
First Name & Middle Initial & Last Name & Degree
Detlev Ameis, Prof.Dr.med.
Facility Name
Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
City
Northeim
ZIP/Postal Code
37154
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Meister, M.D.
Phone
00495551971244
Email
tobias.meister@helios-kliniken.de
First Name & Middle Initial & Last Name & Degree
Tobias Meister, M.D.
First Name & Middle Initial & Last Name & Degree
Martin Floer, M.D.
First Name & Middle Initial & Last Name & Degree
Döner Ufuk
Facility Name
HELIOS Medical Center Siegburg
City
Siegburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Schepke, Prof.Dr.med.
Phone
+49-2241-18-2226
Email
michael.schepke@helios-kliniken.de
First Name & Middle Initial & Last Name & Degree
Michael Schepke, Prof.Dr.med.

12. IPD Sharing Statement

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EndoRings Colonoscopy for Adenoma Detection

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