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Not yet recruiting NCT06468800

Feasibility and Added Value of the TRACMOTION Device for ESD

No phase Interventional Oesophageal Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRACMOTION.
Who it may be relevant to
Registry conditions: Oesophageal Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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).

Interventions

  • Device TRACMOTION
    Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device

Primary outcome measures

  • Procedure time [Time frame: During endoscopic submucosal dissection procedure]
  • Dissection speed [Time frame: During endoscopic submucosal dissection procedure]
  • Lesional damage [Time frame: During endoscopic submucosal dissection and during pathology review (on average 2 weeks after endoscopic submucosal dissection)]
  • Subjective evaluation of the added value of the TRACMOTION device [Time frame: Immediately after endoscopic submucosal dissection]
Secondary outcome measures (3)
  • En-bloc rate [Time frame: Determined Immediately after endoscopic submucosal dissection]
  • R0 rate [Time frame: Determined during the pathology review (on average 2 weeks after endoscopic submucosal dissection)]
  • Complications after during and after endoscopic submucosal dissection [Time frame: During endoscopic submucosal dissection procedure and 2 weeks after]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06468800 · NL87167.078.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗