Adenoma ColonNCT04756453
The Effect of Clip-traction on ESD Resection Time.
A study testing clip-traction in people with Adenoma Colon, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Adenoma Colon
- What is being tested?
- clip-traction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2021to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a lesion in the colon or rectum suitable for removal by the ESD technique
Who cannot join
- dementia
- inability to understand the written study information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Clip-traction on ESD Resection Time. A Randomized Controlled Trial
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.
Read the 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
- Conditions
- Adenoma Colon
- Being tested
- clip-traction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Standard endoscopic submucosal dissection |
| Interventional | Active comparator | Mandatory use of the clip-traction device Receives: Device: clip-traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection speed (mm2/min)
Measured as area of the removed lesion divided by procedure time.
Measured: Within completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start15 Feb 2021
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma ColonStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Marsk, Karolinska Institutet
- Investigators
- Richard Marsk, MD,PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756453
- Sponsor's protocol ID
- 2020-06741
- Status last verified
- Oct 2024
- First submitted
- 11 Feb 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clip-traction on ESD Resection Time. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04756453
- Acronym / sponsor ID
- 2020-06741
- Conditions
- Adenoma Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Standard endoscopic submucosal dissection |
| Interventional | Active comparator | Device: clip-tractionMandatory use of the clip-traction device |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a lesion in the colon or rectum suitable for removal by the ESD technique
Key exclusion criteria (2 listed)
- dementia
- inability to understand the written study information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clip-tractionA 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. | Device | Interventional |
Primary outcome
Resection speed (mm2/min)
Time frame: Within completion of procedure
Measured as area of the removed lesion divided by procedure time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Marsk, MD,PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clip-traction in people with Adenoma Colon, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection speed (mm2/min) (time frame: Within completion of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.