Back to resultsThe Effect of Clip-traction on ESD Resection Time.
Primary Purpose
Adenoma Colon
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
clip-traction
Sponsored by
About this trial
This is an interventional treatment trial for Adenoma Colon
Eligibility Criteria
Inclusion Criteria:
- a lesion in the colon or rectum suitable for removal by the ESD technique
Exclusion Criteria:
- dementia
- inability to understand the written study information
Sites / Locations
- Endoskopicentrum Danderyds SjukhusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard
Interventional
Arm Description
Standard endoscopic submucosal dissection
Mandatory use of the clip-traction device
Outcomes
Primary Outcome Measures
Resection speed (mm2/min)
Measured as area of the removed lesion divided by procedure time.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04756453
Brief Title
The Effect of Clip-traction on ESD Resection Time.
Official Title
The Effect of Clip-traction on ESD Resection Time. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
November 15, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
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
Patients scheduled for an endoscopic submucosal dissection(ESD) in the colorectum will be randomized to the use of a traction device(consisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed, another clip will anchor the loop to adjacent bowel wall) or a standard ESD.
Detailed Description
Patients with an adenoma or an early colorectal cancer treatable with endoscopic submucosal dissection will be randomized to the use of a traction device or a standard ESD. Location, morphology and size of the lesion will be recorded. Time of the procedure will be measured using a stopwatch
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Colon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard
Arm Type
No Intervention
Arm Description
Standard endoscopic submucosal dissection
Arm Title
Interventional
Arm Type
Active Comparator
Arm Description
Mandatory use of the clip-traction device
Intervention Type
Device
Intervention Name(s)
clip-traction
Intervention Description
A endoscopic clip with a loop of tied dental floss will be attached to the lesion. The loop will then be caught by another endoscopic clip and attached to adjacent bowel wall, thus creating tension in the tissue, making dissection easier.
Primary Outcome Measure Information:
Title
Resection speed (mm2/min)
Description
Measured as area of the removed lesion divided by procedure time.
Time Frame
Within completion of procedure
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:
a lesion in the colon or rectum suitable for removal by the ESD technique
Exclusion Criteria:
dementia
inability to understand the written study information
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Marsk, MD,PhD
Phone
+46812358108
Email
richard.marsk@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Björn Törnqvist, MD,PhD
Phone
+46812358477
Email
bjorn.tornqvist@sll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Marsk, MD,PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoskopicentrum Danderyds Sjukhus
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Marsk, PhD
Phone
0707608310
Email
richard.marsk@ki.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Clip-traction on ESD Resection Time.
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