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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
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colon Polyp focused on measuring colonoscopy, polyp, resection

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 8, 2017
Last Updated
June 7, 2019
Sponsor
Technical University of Munich
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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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