Actively Recruiting
The Effect of Clip-traction on ESD Resection Time. A Randomized Controlled Trial
Led by Karolinska Institutet · Updated on 2024-10-15
280
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of using a clip-traction device during endoscopic submucosal dissection (ESD) for patients with adenomas or early colorectal cancer in the colon or rectum. The study compares the use of a traction device against the standard ESD method to see if it impacts the speed of tissue removal. Patients will be randomized into groups to receive either the clip-traction device or the standard procedure. The clip-traction device involves attaching an endoscopic clip with a loop of dental floss to the lesion, which is then anchored to the adjacent bowel wall by another clip to provide tension for easier dissection. One group will undergo the standard ESD without this device, while the other group will have the device used mandatorily. The location, size, and shape of the lesion will be recorded during the procedure. Participants will be monitored during the procedure with the time measured precisely using a stopwatch to assess resection speed in square millimeters per minute. The study tracks these times to compare efficiency between the two methods. The trial is randomized, unblinded, and sponsored by the Karolinska Institutet. The study involves adults aged 18 to 95 years who meet the criteria and excludes those with dementia or inability to understand study information.
CONDITIONS
Brief Title
The Effect of Clip-traction on ESD Resection Time.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A lesion in the colon or rectum suitable for removal by the endoscopic submucosal dissection technique
You will not qualify if you...
- Dementia
- Inability to understand the written study information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day
Participants undergo endoscopic submucosal dissection with either standard technique or with the clip-traction device to facilitate the procedure.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Endoskopicentrum Danderyds Sjukhus
Stockholm, Sweden, 18288
Actively Recruiting
Research Team
R
Richard Marsk, MD,PhD
B
Björn Törnqvist, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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