NCT04756453

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

4.8 years

First QC Date

February 11, 2021

Last Update Submit

October 12, 2024

Conditions

Adenoma Colon

Outcome Measures

Primary Outcomes (1)

  • Resection speed (mm2/min)

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

    Within completion of procedure

Study Arms (2)

Standard

NO INTERVENTION

Standard endoscopic submucosal dissection

Interventional

ACTIVE COMPARATOR

Mandatory use of the clip-traction device

Device: clip-traction

Interventions

clip-tractionDEVICE

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.

Interventional

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a lesion in the colon or rectum suitable for removal by the ESD technique

You may not qualify if:

  • dementia
  • inability to understand the written study information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoskopicentrum Danderyds Sjukhus

Stockholm, 18288, Sweden

RECRUITING

Study Officials

  • Richard Marsk, MD,PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Marsk, MD,PhD

CONTACT

+46812358108richard.marsk@ki.se

Björn Törnqvist, MD,PhD

CONTACT

+46812358477bjorn.tornqvist@sll.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 16, 2021

Study Start

February 15, 2021

Primary Completion

November 15, 2025

Study Completion

November 15, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)