The Effect of Clip-traction on ESD Resection Time.

NCT ID: NCT04756453

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2025-11-15

Brief Summary

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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

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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

Conditions

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Adenoma Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard

Standard endoscopic submucosal dissection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventional

Mandatory use of the clip-traction device

Group Type ACTIVE_COMPARATOR

clip-traction

Intervention Type 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.

Interventions

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clip-traction

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Richard Marsk

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Marsk, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Endoskopicentrum Danderyds Sjukhus

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Richard Marsk, MD,PhD

Role: CONTACT

+46812358108

Björn Törnqvist, MD,PhD

Role: CONTACT

+46812358477

Facility Contacts

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Richard Marsk, PhD

Role: primary

0707608310

Other Identifiers

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2020-06741

Identifier Type: -

Identifier Source: org_study_id

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