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Trial Title:
Feasibility and Added Value of the TRACMOTION Device for ESD
NCT ID:
NCT06468800
Condition:
Oesophageal Neoplasm
Conditions: Official terms:
Esophageal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
TRACMOTION
Description:
Patients already scheduled for ESD will undergo an ESD procedure with the aid of the
Tracmotion device
Arm group label:
ESD with TRACMOTION
Summary:
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06468800
