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

NCT07263997 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-04

No results posted yet for this study

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. 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.

Conditions

  • Colorectal Cancer (MSI-H)

Interventions

DEVICE

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.

Sponsors & Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2027-01-15
Completion
2027-01-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07263997 on ClinicalTrials.gov