NCT07263997: COLOTRACT

Assessment of a New Traction Device in Submucosal Dissection of Colorectal Lesions

Not yet recruiting NA Last updated 4 December 2025

What this trial tests

NA trial testing SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection. in Colorectal Cancer (MSI-H) in 30 participants. Not yet recruiting.

Timeline

15 December 2025

Primary endpoint
15 January 2027

15 January 2027

Quick facts

Lead sponsor	GCS Ramsay Santé pour l'Enseignement et la Recherche
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	15 December 2025
Primary completion	15 January 2027
Estimated completion	15 January 2027
Sites	1 location across France

Drugs / interventions tested

• SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection.

Conditions studied

• Colorectal Cancer (MSI-H) — all drugs for Colorectal Cancer (MSI-H) →

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer (MSI-H). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.