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EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034929
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Tobias Meister, Helios Albert-Schweitzer-Klinik Northeim

Study Description
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Brief Summary:

The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.

The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.

The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.


Condition or disease Intervention/treatment Phase
Polyp Adenoma Cancer Device: EndoCuff-assisted colonoscopy Device: Standard colonoscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas
Study Start Date : January 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Endocuff-assisted colonoscopy
Endocuff-assisted colonoscopy
 Device: EndoCuff-assisted colonoscopy
EC-assisted colonoscopy
Active Comparator: Standard colonoscopy
Standard Colonoscopy
 Device: Standard colonoscopy
Standard colonoscopy


Outcome Measures
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Primary Outcome Measures :
  1. adenoma detection rate [ Time Frame: 25 minutes ]
    completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.


Secondary Outcome Measures :
  1. polyp detection rate [ Time Frame: 1 Week ]
  2. number of LGIN and HGIN adenomas detected [ Time Frame: one week ]
    LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia

  3. polyp distribution [ Time Frame: 25 minutes ]
  4. procedure time [ Time Frame: 25 Minutes ]
  5. withdrawal time [ Time Frame: 10 Minutes ]
    without intervention time due to polypectomy

  6. ileum intubation rate [ Time Frame: 10 minutes ]
  7. total colonoscopy rate [ Time Frame: 25 minutes ]
  8. adverse events [ Time Frame: 25 minutes ]
    perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent

Exclusion Criteria:

  • pregnancy
  • age<18 years
  • known colonic strictures
  • chronic inflammatory bowel disease
  • active inflammation
  • s/p colonic resection
Contacts and Locations
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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): NCT02034929


Locations
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Germany
University Medical Center Göttingen
Göttingen, Germany, 37575
HELIOS St. Marienberg Hospital Helmstedt
Helmstedt, Germany, 38350
Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
Northeim, Germany, 37154
HELIOS Medical Center Siegburg, Department of Gastroenterology
Siegburg, Germany, 53721
Sponsors and Collaborators
Helios Albert-Schweitzer-Klinik Northeim
Investigators
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Principal Investigator: Tobias Meister, M.D. Helios Albert-Schweitzer-Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tobias Meister, PD Dr. med., Helios Albert-Schweitzer-Klinik Northeim
ClinicalTrials.gov Identifier: NCT02034929    
Other Study ID Numbers: HRS ID 003053
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Keywords provided by Tobias Meister, Helios Albert-Schweitzer-Klinik Northeim:
colon cancer
adenoma
colon polyps
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms