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Trial record 2 of 301 for:    Recruiting, Not yet recruiting, Available Studies | "Adenoma"

EndoRings Colonoscopy for Adenoma Detection (ER)

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ClinicalTrials.gov Identifier: NCT03469622
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Helios Albert-Schweitzer-Klinik Northeim

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


Condition or disease Intervention/treatment Phase
Adenoma Device: EndoRings Device: Standard colonoscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: EndoRings Versus Standard Colonoscopy for Adenoma Detection
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: EndoRings
Colonoscopy is performed with the EndoRings attached
Device: EndoRings
EndoRings-assisted colonoscopy

Active Comparator: Standard Colonoscopy
Standard colonoscopy without any additional devices
Device: Standard colonoscopy
Standard colonoscopy without any additional devices




Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: during colonoscopy ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469622


Contacts
Contact: Tobias Meister, Prof. Dr. +495551971244 tobias.meister@helios-gesundheit.de

Locations
Germany
HELIOS HSK Kliniken Recruiting
Wiesbaden, Hessen, Germany, 65199
Contact: Ralf Kiesslich, Prof. Dr.    +49611432420    ralf.kiesslich@helios-gesundheit.de   
Department of Gastroenterology, University Medical Center Recruiting
Göttingen, Lower Saxony, Germany, 37075
Contact: Volker Ellenrieder, Professor    +49551390    Volker.Ellenrieder@med.uni-goettingen.de   
HELIOS St. Marienberg Klinik Helmstedt Recruiting
Helmstedt, Germany
Contact: Detlev Ameis, Prof.Dr.med.    0049 53 51 14 - 0    detlev.ameis@helios-kliniken.de   
Principal Investigator: Detlev Ameis, Prof.Dr.med.         
Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital Recruiting
Northeim, Germany, 37154
Contact: Tobias Meister, M.D.    00495551971244    tobias.meister@helios-kliniken.de   
Principal Investigator: Tobias Meister, M.D.         
Sub-Investigator: Martin Floer, M.D.         
Sub-Investigator: Döner Ufuk         
HELIOS Medical Center Siegburg Recruiting
Siegburg, Germany
Contact: Michael Schepke, Prof.Dr.med.    +49-2241-18-2226    michael.schepke@helios-kliniken.de   
Principal Investigator: Michael Schepke, Prof.Dr.med.         
Sponsors and Collaborators
Helios Albert-Schweitzer-Klinik Northeim
Investigators
Principal Investigator: Tobias Meister, Prof. Dr. HELIOS Albert-Schweitzer Klinik
Principal Investigator: Ralf Kiesslich, Prof. Dr. HELIOS HSK Kliniken Wiesbaden

Responsible Party: Helios Albert-Schweitzer-Klinik Northeim
ClinicalTrials.gov Identifier: NCT03469622     History of Changes
Other Study ID Numbers: HRC 047721
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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

Keywords provided by Helios Albert-Schweitzer-Klinik Northeim:
Adenoma
Polyp
EndoRings
Colonoscopy
Endoscopic device
Colon cancer screening

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms