Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum (EVASTA)
Primary Purpose
Colon Polyp
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Endocuff Vision assisted polypectomy
Standard polypectomy
Sponsored by
About this trial
This is an interventional prevention trial for Colon Polyp focused on measuring colonoscopy, polyp, resection
Eligibility Criteria
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:
-
Sites / Locations
- Klinikum rechts der Isar der TU München
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Standard Arm
Endocuff Vision Arm
Arm Description
Standard colonoscopy without mounted Endocuff Vision device. Therefore standard polypectomy in case of polyp resection.
Endocuff Vision device mounted to the endoscope prior to the beginning of the procedure. Therefore EVD assisted polypectomy in case of polyp resection.
Outcomes
Primary Outcome Measures
Polyp resection
Time of polyp resection will be measured using a stopwatch.
Secondary Outcome Measures
Polyp detection
a maximum of one day is expected for colonoscopy procedures
Cecal intubation time
Time span until cecum is reached with the tip of the scope
Ileum intubation time
Time span until ileum is reached
Total procedure duration
Total procedure duration
Complications
Bleeding, perforation and other complications
Propofol dosage
Amount of propofol used for colonoscopy
Patient satisfaction
Measured on a 10 point numeric scale
Full Information
NCT ID
NCT03117114
First Posted
April 8, 2017
Last Updated
June 7, 2019
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT03117114
Brief Title
Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum
Acronym
EVASTA
Official Title
Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
June 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp
Keywords
colonoscopy, polyp, resection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Arm
Arm Type
Other
Arm Description
Standard colonoscopy without mounted Endocuff Vision device. Therefore standard polypectomy in case of polyp resection.
Arm Title
Endocuff Vision Arm
Arm Type
Active Comparator
Arm Description
Endocuff Vision device mounted to the endoscope prior to the beginning of the procedure. Therefore EVD assisted polypectomy in case of polyp resection.
Intervention Type
Device
Intervention Name(s)
Endocuff Vision assisted polypectomy
Intervention Description
EVD mounted to the tip of the endoscope, therefore EVD assisted polypectomy
Intervention Type
Other
Intervention Name(s)
Standard polypectomy
Intervention Description
Absence of an EVD, standard polypectomy
Primary Outcome Measure Information:
Title
Polyp resection
Description
Time of polyp resection will be measured using a stopwatch.
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)]
Secondary Outcome Measure Information:
Title
Polyp detection
Description
a maximum of one day is expected for colonoscopy procedures
Time Frame
up to day 1
Title
Cecal intubation time
Description
Time span until cecum is reached with the tip of the scope
Time Frame
up to day 1
Title
Ileum intubation time
Description
Time span until ileum is reached
Time Frame
up to day 1
Title
Total procedure duration
Description
Total procedure duration
Time Frame
up to day 1
Title
Complications
Description
Bleeding, perforation and other complications
Time Frame
up to day 1
Title
Propofol dosage
Description
Amount of propofol used for colonoscopy
Time Frame
up to day 1
Title
Patient satisfaction
Description
Measured on a 10 point numeric scale
Time Frame
up to day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Klare, MD
Organizational Affiliation
Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum rechts der Isar der TU München
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81657
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31614373
Citation
von Figura G, Hasenohrl M, Haller B, Poszler A, Ulrich J, Brown H, Abdelhafez M, Schmid RM, von Delius S, Klare P. Endocuff vision-assisted vs. standard polyp resection in the colorectum (the EVASTA study): a prospective randomized study. Endoscopy. 2020 Jan;52(1):45-51. doi: 10.1055/a-1018-1870. Epub 2019 Oct 15.
Results Reference
derived
Learn more about this trial
Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum
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