Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope

Cap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope

Standard colonoscopy without any additional device

Arc Endocuff (AEC 110, 120, 130, 140)

Olympus Disposable distal attachment 15mm diameter, 4mm depth

Standard colonoscope

Tobias Meister, Prof. Dr.med.

Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)

The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.

Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study

Proportion of patients having at least one adenoma

Helios Albert-Schweitzer-Klinik Northeim

Prof. Dr. med. Tobias Meister

Digestive System Diseases

Pain

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The standard colonoscope used world-wide today.

Screening colonoscopy with a prototype colonoscope

Olympus PCF-Y0014-L

Michael Bretthauer, MD, Ph.d.

The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.

Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants.

The time used to reach the caecum will be recorded with a stop watch during the procedure.

If sedation/analgesics is administered during the colonoscopy procedure, the name of the agent, dose and route of administration will be recorded immediately.

If the colonoscopist decides to change to a different colonoscope during the procedure, the reason is recorded immediately after the procedure. The number of procedures where there is a change of colonoscope will be recorded.

The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy	NCT02331836	Colorectal Poly... Colorectal Aden...	Arc Endocuff (A... Cap Standard colono...	18 Years -	Helios Albert-Schweitzer-Klinik Northeim
Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial	NCT01370928	Colorectal Canc... Adenomas	Olympus PCF-Y00... Standard colono...	54 Years - 64 Years	Sorlandet Hospital HF
Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial	NCT01370928	Colorectal Canc... Adenomas	Olympus PCF-Y00... Standard colono...	54 Years - 64 Years	Sorlandet Hospital HF
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy	NCT02331836	Colorectal Poly... Colorectal Aden...	Arc Endocuff (A... Cap Standard colono...	18 Years -	Helios Albert-Schweitzer-Klinik Northeim

Spots Global Cancer Trial Database for standard colonoscope