Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04756453

The Effect of Clip-traction on ESD Resection Time.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Adenoma Colon

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoskopicentrum Danderyds Sjukhus

Stockholm, 18288, Sweden

Location status: Recruiting

Location contact

Richard Marsk, PhD

CONTACT

[email protected]

0707608310

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clip-traction

Device

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 outcomes

  1. Resection speed (mm2/min)

    Time frame: Within completion of procedure

    Measured as area of the removed lesion divided by procedure time.

Study contacts

Contact information is provided by the study sponsor or research team.

Björn Törnqvist, MD,PhD

CONTACT

[email protected]

+46812358477

Richard Marsk, MD,PhD

CONTACT

[email protected]

+46812358108

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

The Effect of Clip-traction on ESD Resection Time. A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 16, 2021
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.