Klinikum rechts der Isar der TU München
Munich, Bavaria, 81657, Germany
NCT Number: NCT03117114
Adenomas are premalignant polyps of the colon that should be resected endoscopically. Complete resection of adenomatous polyps is the major task of colonoscopy. In some cases polyp may be poorly accessible making endoscopic resection difficult. Polypectomy may be conducted using the so-called piece meal technique in these cases. However, leaving polyp residual polyps in the colon bears the risk of malignant degeneration as colorectal cancer may arise form adenomatous remnants. In case of difficult polyp locations endoscopic resection may also be time consuming. On the other hand endoscopists are facing an increased time pressure due to rising numbers of procedures during the last decades.
The Endocuff Vision device (EVD) is a cap that can be mounted to the tip of a standard endoscope. The EVD has small flexible branches on its outside. The branches turn out during withdrawal. By that the branches are getting in contact with colonic wall. This mechanism leads to a more stabilized position of the colonoscope in the bowel. It is hypothesized that resection circumstances may be improved by using an EVD. In addition, stabilizing the scope during resection may result in a reduced time effort. Until now no controlled trials exist investigating the effect of EVD on the time effect during polyp resection. Therefore a randomized controlled trial needed comparing standard polypectomy versus polypectomy using the EVD during routine colonoscopy procedures.
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Notify Me18 year–95 year
All sexes
Interventional
Not applicable
Munich, Bavaria, 81657, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
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EVD mounted to the tip of the endoscope, therefore EVD assisted polypectomy
Absence of an EVD, standard polypectomy
Time frame: up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)]
Time of polyp resection will be measured using a stopwatch.
Time frame: up to day 1
a maximum of one day is expected for colonoscopy procedures
Time frame: up to day 1
Time span until cecum is reached with the tip of the scope
Time frame: up to day 1
Time span until ileum is reached
Time frame: up to day 1
Total procedure duration
Time frame: up to day 1
Bleeding, perforation and other complications
Time frame: up to day 1
Amount of propofol used for colonoscopy
Time frame: up to day 1
Measured on a 10 point numeric scale
Technical University of Munich
Other
Acronym: EVASTA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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