Feasibility and Added Value of the TRACMOTION Device for ESD

Erasmus University

Status

Not yet enrolling

Conditions

Oesophageal Neoplasm

Treatments

Device: TRACMOTION

Study type

Interventional

Funder types

Other

Identifiers

NCT06468800

NL87167.078.24

Details and patient eligibility

About

A single center non-randomized prospective clinical study, to evaluate the feasibility and added value of the CE-certified Tracmotion device in patients scheduled consecutively for ESD in the upper and lower gastrointestinal tract.

After ESD, the endoscopists' opinion will be evaluated with a short questionnaire on experience with the Tracmotion device. The pathology report will be checked for radicality and microscopic damage of the removed lesion.

Full description

Objective: The purpose of this study is to establish feasibility of the Tracmotion device for ESD and to define its added value during ESD in both upper and lower GI procedures, both in antegrade and in retroflex positions.

Study design: Single center prospective observational non-randomized clinical study.

Study population: A total of 20 consecutive cases scheduled for ESD will be included. Sample size calculation does not apply for this type of study. Patients already scheduled for ESD will undergo an ESD procedure as planned with the aid of the Tracmotion device. It is anticipated that the Tracmotion will provide superior traction and counter traction compared to off-label tools.

Intervention: Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device.

Main study parameters/endpoints:

Feasibility: procedure time, dissection speed, lesional damage (tearing or grasping injury to the mucosa on macroscopy and pathological review) Added value: subjective evaluation of the Tracmotion device by the performing endoscopist (contentment of use of Tracmotion, difference in procedure time, stability of, control of and accessibility to the lesion).

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients scheduled for endoscopic submucosal dissection (upper and lower gastrointestinal tract);
Lesion is accessible with a therapeutic endoscope;
Written informed consent;
Age ≥18 years.

Exclusion criteria

Coagulopathy (not corrected prior to endoscopic submucosal dissection);
Participating in a different experimental drug/device trial in the previous 3 months.