Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

Colon Polyp Clinical Trial

— EVASTA  

Official title:

Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117114
• Other study ID #: EVASTA
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 6, 2019

Study information

• Verified date: June 2019
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 6, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• indication for colonoscopy

• age = 40 years

Exclusion Criteria:

• American Society of Anesthesiologists class IV or higher

• pregnant women

• indication for colonoscopy: inflammatory bowel disease

• indication for colonoscopy: polyposis syndrome

• indication for colonoscopy: emergency colonoscopy e.g. acute bleeding

• contraindication for polyp resection e.g. patients on warfarin

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Colon Polyp
• Polyps

Intervention

Device:
• Endocuff Vision assisted polypectomy
EVD mounted to the tip of the endoscope, therefore EVD assisted polypectomy

Other:
• Standard polypectomy
Absence of an EVD, standard polypectomy

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar der TU München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polyp resection	Time of polyp resection will be measured using a stopwatch.	up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)]
Secondary	Polyp detection	a maximum of one day is expected for colonoscopy procedures	up to day 1
Secondary	Cecal intubation time	Time span until cecum is reached with the tip of the scope	up to day 1
Secondary	Ileum intubation time	Time span until ileum is reached	up to day 1
Secondary	Total procedure duration	Total procedure duration	up to day 1
Secondary	Complications	Bleeding, perforation and other complications	up to day 1
Secondary	Propofol dosage	Amount of propofol used for colonoscopy	up to day 1
Secondary	Patient satisfaction	Measured on a 10 point numeric scale	up to day 1