Colorectal Cancer (MSI-H)COLOTRACTNCT07263997
Assessment of a New Traction Device in Submucosal Dissection of Colorectal Lesions
A study testing SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection. in people with Colorectal Cancer (MSI-H), run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Colorectal cancer is a major public health issue. In France, in 2015, there were 40,000 new cases and 17,000 deaths. It develops from adenomas or scalloped polyps, which are usually accessible for endoscopic resection. Piece-meal mucosectomy is the standard technique in Europe and the USA for lesions larger than 2 cm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (MSI-H)
- What is being tested?
- SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2025to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, aged ≥ 18 years old
- Patient with a colorectal lesion larger than 2 cm
- Patient eligible for SMD with elastic traction
- Patient affiliated with or beneficiary of a social security scheme
- French-speaking patient who has signed an informed consent form
Who cannot join
- Patients in poor general health who should not undergo endoscopy.
- Patients with an upper digestive tract that cannot be accessed by the endoscope.
- Patients with severe coagulation disorders and diseases associated with a risk of haemorrhage (platelets <50G/L, PT < 50%, INR > 1.5, APTT >1.5).
- Patients who are allergic to the instrument and to the drugs administered during the operation
- Patients who are not compatible with the use of the product according to the diagnosis Patients with lesions located in the appendix, ileocecal valve or within a diverticulum
- Patients with lesions that present a risk of deep submucosal invasion based on their morphological appearance (Kudo lesion > 10 mm or Sano IIIB > 10 mm or connect III)
Show all 13Show fewer
- Patients with recurrence of a lesion previously resected by endoscopy or surgery
- Patients with a history of chronic inflammatory bowel disease (IBD) or familial adenomatous polyposis (FAP)
- Patients with a history of pelvic radiotherapy
- Patients for whom follow-up data cannot be collected
- Pregnant women
- Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
- Patients hospitalised without consent
Trial locations and contacts
1 site in 1 country.
About this study
Colorectal cancer is a major public health issue. In France, in 2015, there were 40,000 new cases and 17,000 deaths. It develops from adenomas or scalloped polyps, which are usually accessible for endoscopic resection.
Piece-meal mucosectomy is the standard technique in Europe and the USA for lesions larger than 2 cm. It has certain advantages, such as its ease of learning, low morbidity and speed of execution. However, it has one major disadvantage, namely the low rate of monobloc resection and R0 for lesions larger than 2 cm.
Read more
Submucosal dissection (SMD) has become the standard technique for endoscopic resection of superficial colorectal lesions larger than 2 cm, particularly if the lesion presents a risk of superficial degeneration. Unlike mucosectomy, this technique allows for monobloc resection targeting R0 for all types of superficial lesions without size limitations, enabling histological analysis without data loss and with a recurrence rate of less than 2%.
However, there are numerous disadvantages to dissection:
- SMD is more difficult than mucosectomy, with a long learning curve, limiting its use to expert centres.
- The morbidity of dissection is higher than that of mucosectomy, with a risk of perforation of 4% vs. 1%.
- The procedure takes on average three times longer than mucosectomy.
From a technical standpoint, various methods have been described to facilitate the procedure, in particular traction using clips and elastic bands, which is the most widely used method in France.
Micro-Tech offers a new traction device, SureTrac, which is designed to perform single or multi-polar traction and to adjust the intensity of traction during dissection. The product is CE marked but has not yet been distributed in France. No data are currently available in the literature on this product other than a case report submitted for publication. A pilot study conducted by an expert centre is therefore necessary. This is why this study is being initiated.
Read the detailed description
Colorectal cancer is a major public health issue. In France, in 2015, there were 40,000 new cases and 17,000 deaths. It develops from adenomas or scalloped polyps, which are usually accessible for endoscopic resection.
The larger the size of the colonic lesion, the higher the risk of degeneration, and the more difficult and risky endoscopic resection becomes. Nevertheless, this risk is still lower than that of surgery, which has a morbidity rate of 24%.
Piece-meal mucosectomy is the standard technique in Europe and the USA for lesions larger than 2 cm. It has certain advantages, such as its ease of learning, low morbidity and speed of execution. However, it has one major disadvantage, namely the low rate of monobloc resection and R0 for lesions larger than 2 cm. In this indication, it is therefore debatable because the risk of recurrence is 15%, or even 30% for lesions larger than 4 cm. Histological analysis is potentially less reliable, with the risk of losing histological fragments and only partially examining the specimens. This can potentially bias the decision to perform additional surgery or follow-up. Finally, the need to perform repeated colonoscopies in the event of recurrence or during monitoring leads to additional costs and a loss of patient follow-up.
Submucosal dissection (SMD) has become the standard technique for endoscopic resection of superficial colorectal lesions larger than 2 cm, particularly if the lesion presents a risk of superficial degeneration. Unlike mucosectomy, this technique allows for monobloc resection targeting R0 for all types of superficial lesions without size limitations, enabling histological analysis without data loss and with a recurrence rate of less than 2%.
However, there are numerous disadvantages to dissection:
- SMD is more difficult than mucosectomy, with a long learning curve, limiting its use to expert centres.
- The morbidity of dissection is higher than that of mucosectomy, with a risk of perforation of 4% vs. 1%.
- The procedure takes on average three times longer than mucosectomy.
From a technical standpoint, various methods have been described to facilitate the procedure, in particular traction using clips and elastic bands, which is the most widely used method in France. This involves pulling the lesion using a clip and elastic band to open up the submucosal layer and facilitate dissection. Certain variations have been described, such as multi-traction and adaptive traction, which are performed using non-dedicated, off-label devices (haemostatic clip and dental elastic band).
Micro-Tech offers a new traction device, SureTrac, which is designed to perform single or multi-polar traction and to adjust the intensity of traction during dissection. The product is CE marked but has not yet been distributed in France. No data are currently available in the literature on this product other than a case report submitted for publication. A pilot study conducted by an expert centre is therefore necessary. This is why this study is being initiated.
- Conditions
- Colorectal Cancer (MSI-H)
- Being tested
- SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection.
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection.Device
The SureTrac device consists of a main attachment clip to which an elastic silicone device comprising four aligned rings is attached. The device is designed to retract and release elastic potential energy for dynamic traction. This allows for better visualisation of tissues and facilitates Submucosal dissection of colorectal lesions.
| Study group | Role | What they receive |
|---|---|---|
| SureTrac aArm | Experimental | SureTrac™ traction device i sused to perform submucosal dissection Receives: Device: SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Submucosal dissection feasibility with the SureTrac traction device.
Feasibilty will be the rate of monobloc resection with the SureTrac device. Monobloc resection requiring another device or fragmented resection (regardless of the device) will be considered a failure.
Measured: Day 0 (resection day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start25 Nov 2025
- 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 Colorectal Cancer (MSI-H)Studies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263997
- Sponsor's protocol ID
- 2025-A01865-44
- Acronym
- COLOTRACT
- Status last verified
- Aug 2026
- First submitted
- 23 Nov 2025
- Last updated
- 20 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a New Traction Device in Submucosal Dissection of Colorectal Lesions
- ClinicalTrials.gov ID
- NCT07263997
- Acronym / sponsor ID
- COLOTRACT / 2025-A01865-44
- Conditions
- Colorectal Cancer (MSI-H)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 4 Dec 2025 (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.
Colorectal cancer is a major public health issue. In France, in 2015, there were 40,000 new cases and 17,000 deaths. It develops from adenomas or scalloped polyps, which are usually accessible for endoscopic resection.
Piece-meal mucosectomy is the standard technique in Europe and the USA for lesions larger than 2 cm. It has certain advantages, such as its ease of learning, low morbidity and speed of execution. However, it has one major disadvantage, namely the low rate of monobloc resection and R0 for lesions larger than 2 cm.
Submucosal dissection (SMD) has become the standard technique for endoscopic resection of superficial colorectal lesions larger than 2 cm, particularly if the lesion presents a risk of superficial degeneration. Unlike mucosectomy, this technique allows for monobloc resection targeting R0 for all types of superficial lesions without size limitations, enabling histological analysis without data loss and with a recurrence rate of less than 2%.
However, there are numerous disadvantages to dissection:
- SMD is more difficult than mucosectomy, with a long learning curve, limiting its use to expert centres.
- The morbidity of dissection is higher than that of mucosectomy, with a risk of perforation of 4% vs. 1%.
- The procedure takes on average three times longer than mucosectomy.
From a technical standpoint, various methods have been described to facilitate the procedure, in particular traction using clips and elastic bands, which is the most widely used method in France.
Micro-Tech offers a new traction device, SureTrac, which is designed to perform single or multi-polar traction and to adjust the intensity of traction during dissection. The product is CE marked but has not yet been distributed in France. No data are currently available in the literature on this product other than a case report submitted for publication. A pilot study conducted by an expert centre is therefore necessary. This is why this study is being initiated.
Detailed description
Colorectal cancer is a major public health issue. In France, in 2015, there were 40,000 new cases and 17,000 deaths. It develops from adenomas or scalloped polyps, which are usually accessible for endoscopic resection.
The larger the size of the colonic lesion, the higher the risk of degeneration, and the more difficult and risky endoscopic resection becomes. Nevertheless, this risk is still lower than that of surgery, which has a morbidity rate of 24%.
Piece-meal mucosectomy is the standard technique in Europe and the USA for lesions larger than 2 cm. It has certain advantages, such as its ease of learning, low morbidity and speed of execution. However, it has one major disadvantage, namely the low rate of monobloc resection and R0 for lesions larger than 2 cm. In this indication, it is therefore debatable because the risk of recurrence is 15%, or even 30% for lesions larger than 4 cm. Histological analysis is potentially less reliable, with the risk of losing histological fragments and only partially examining the specimens. This can potentially bias the decision to perform additional surgery or follow-up. Finally, the need to perform repeated colonoscopies in the event of recurrence or during monitoring leads to additional costs and a loss of patient follow-up.
Submucosal dissection (SMD) has become the standard technique for endoscopic resection of superficial colorectal lesions larger than 2 cm, particularly if the lesion presents a risk of superficial degeneration. Unlike mucosectomy, this technique allows for monobloc resection targeting R0 for all types of superficial lesions without size limitations, enabling histological analysis without data loss and with a recurrence rate of less than 2%.
However, there are numerous disadvantages to dissection:
- SMD is more difficult than mucosectomy, with a long learning curve, limiting its use to expert centres.
- The morbidity of dissection is higher than that of mucosectomy, with a risk of perforation of 4% vs. 1%.
- The procedure takes on average three times longer than mucosectomy.
From a technical standpoint, various methods have been described to facilitate the procedure, in particular traction using clips and elastic bands, which is the most widely used method in France. This involves pulling the lesion using a clip and elastic band to open up the submucosal layer and facilitate dissection. Certain variations have been described, such as multi-traction and adaptive traction, which are performed using non-dedicated, off-label devices (haemostatic clip and dental elastic band).
Micro-Tech offers a new traction device, SureTrac, which is designed to perform single or multi-polar traction and to adjust the intensity of traction during dissection. The product is CE marked but has not yet been distributed in France. No data are currently available in the literature on this product other than a case report submitted for publication. A pilot study conducted by an expert centre is therefore necessary. This is why this study is being initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SureTrac aArm | Experimental | Device: SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection.SureTrac™ traction device i sused to perform submucosal dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient, male or female, aged ≥ 18 years old
- Patient with a colorectal lesion larger than 2 cm
- Patient eligible for SMD with elastic traction
- Patient affiliated with or beneficiary of a social security scheme
- French-speaking patient who has signed an informed consent form
Key exclusion criteria (13 listed)
- Patients in poor general health who should not undergo endoscopy.
- Patients with an upper digestive tract that cannot be accessed by the endoscope.
- Patients with severe coagulation disorders and diseases associated with a risk of haemorrhage (platelets <50G/L, PT < 50%, INR > 1.5, APTT >1.5).
- Patients who are allergic to the instrument and to the drugs administered during the operation
- Patients who are not compatible with the use of the product according to the diagnosis Patients with lesions located in the appendix, ileocecal valve or within a diverticulum
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 |
|---|---|---|
| SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection.The SureTrac device consists of a main attachment clip to which an elastic silicone device comprising four aligned rings is attached. The device is designed to retract and release elastic potential energy for dynamic traction. This allows for better visualisation of tissues and facilitates Submucosal dissection of colorectal lesions. | Device | SureTrac aArm |
Primary outcome
Submucosal dissection feasibility with the SureTrac traction device.
Time frame: Day 0 (resection day)
Feasibilty will be the rate of monobloc resection with the SureTrac device. Monobloc resection requiring another device or fragmented resection (regardless of the device) will be considered a failure.
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 20 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection. in people with Colorectal Cancer (MSI-H), run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 5 inclusion and 13 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 20 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 France. 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?
Submucosal dissection feasibility with the SureTrac traction device. (time frame: Day 0 (resection day)). 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 20 Aug 2026.