EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tobias Meister, Helios Albert-Schweitzer-Klinik Northeim
ClinicalTrials.gov Identifier:
NCT02034929
First received: January 6, 2014
Last updated: August 9, 2014
Last verified: August 2014
  Purpose

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 Intervention
Polyp
Adenoma
Cancer
Device: EndoCuff-assisted colonoscopy
Device: Standard colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas

Resource links provided by NLM:


Further study details as provided by Helios Albert-Schweitzer-Klinik Northeim:

Primary Outcome Measures:
  • adenoma detection rate [ Time Frame: 25 minutes ] [ Designated as safety issue: No ]
    completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.


Secondary Outcome Measures:
  • polyp detection rate [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
  • number of LGIN and HGIN adenomas detected [ Time Frame: one week ] [ Designated as safety issue: No ]
    LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia

  • polyp distribution [ Time Frame: 25 minutes ] [ Designated as safety issue: No ]
  • procedure time [ Time Frame: 25 Minutes ] [ Designated as safety issue: No ]
  • withdrawal time [ Time Frame: 10 Minutes ] [ Designated as safety issue: No ]
    without intervention time due to polypectomy

  • ileum intubation rate [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
  • total colonoscopy rate [ Time Frame: 25 minutes ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 25 minutes ] [ Designated as safety issue: Yes ]
    perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy


Enrollment: 500
Study Start Date: January 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034929

Locations
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
Principal Investigator: Tobias Meister, M.D. Helios Albert-Schweitzer-Hospital
  More Information

No publications provided

Responsible Party: Tobias Meister, PD Dr. med., Helios Albert-Schweitzer-Klinik Northeim
ClinicalTrials.gov Identifier: NCT02034929     History of Changes
Other Study ID Numbers: HRS ID 003053
Study First Received: January 6, 2014
Last Updated: August 9, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Helios Albert-Schweitzer-Klinik Northeim:
colon cancer
adenoma
colon polyps

Additional relevant MeSH terms:
Adenoma
Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014