Feasibility and Added Value of the TRACMOTION Device for ESD
- Conditions
- Oesophageal Neoplasm
- Interventions
- Device: TRACMOTION
- Registration Number
- NCT06468800
- Lead Sponsor
- Erasmus Medical Center
- Brief 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Patients scheduled for endoscopic submucosal dissection (upper and lower gastrointestinal tract);
- Lesion is accessible with a therapeutic endoscope;
- Written informed consent;
- Age ≥18 years.
- Coagulopathy (not corrected prior to endoscopic submucosal dissection);
- Participating in a different experimental drug/device trial in the previous 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ESD with TRACMOTION TRACMOTION Patients already scheduled for ESD will undergo an ESD procedure with the aid of the TRACMOTION device.
- Primary Outcome Measures
Name Time Method Dissection speed During endoscopic submucosal dissection procedure Dissection speed of ESD will be measured from start incision to end incision (square millimeter of dissected tissue per minute)
Procedure time During endoscopic submucosal dissection procedure Procedure time of the endoscopic submucosal dissection will be measured from start incision to end incision (in minutes)
Subjective evaluation of the added value of the TRACMOTION device Immediately after endoscopic submucosal dissection Directly after the endoscopic mucosal dissection the endoscopist will fill in a questionnaire using the Likert scale (1= worst experience possible, 5 = best experience possible) about their experience with the TRACMOTION device during ESD (overall contentment, difference of procedure time, stability of, control of and accessibility to the lesion that was resected)
Lesional damage During endoscopic submucosal dissection and during pathology review (on average 2 weeks after endoscopic submucosal dissection) Any tearing or grasping injury to the mucosa on macroscopy (yes vs. no) observed by the endoscopist and at pathological review (yes/no) observed by the pathologist expressed in percentages (%).
- Secondary Outcome Measures
Name Time Method En-bloc rate Determined Immediately after endoscopic submucosal dissection The incidence of en-bloc resections in percentages (%)
R0 rate Determined during the pathology review (on average 2 weeks after endoscopic submucosal dissection) The incidence of R0 resections in percentages (%)
Complications after during and after endoscopic submucosal dissection During endoscopic submucosal dissection procedure and 2 weeks after Complications will be measured during and after endoscopic submucosal dissection (bleeding yes/no, perforation yes/no) and will be expressed as percentages (%)