Clinical trial NCT06468800: Feasibility and Added Value of the TRACMOTION Device for ESD
Official title: Feasibility and Added Value of the TRACMOTION Device for ESD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oesophageal Neoplasm
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Procedure time
timeFrame: During endoscopic submucosal dissection procedure
measure: Dissection speed
timeFrame: During endoscopic submucosal dissection procedure
measure: Lesional damage
timeFrame: During endoscopic submucosal dissection and during pathology review (on average 2 weeks after endoscopic submucosal dissection)
measure: Subjective evaluation of the added value of the TRACMOTION device
timeFrame: Immediately after endoscopic submucosal dissection
Secondary outcomes:
measure: En-bloc rate
timeFrame: Determined Immediately after endoscopic submucosal dissection
measure: R0 rate
timeFrame: Determined during the pathology review (on average 2 weeks after endoscopic submucosal dissection)
measure: Complications after during and after endoscopic submucosal dissection
timeFrame: During endoscopic submucosal dissection procedure and 2 weeks after
Other outcomes:
measure: Age
timeFrame: At baseline (after informed consent is signed)
measure: Gender
timeFrame: At baseline (after informed consent is signed)
measure: Tumor length
timeFrame: During endoscopic submucosal dissection, before incision starts
measure: Tumor location
timeFrame: During endoscopic submucosal dissection, before incision starts
measure: Tumor histology
timeFrame: After endoscopic submucosal dissection when the pathologist has reviewed the tissue (on average 2 weeks after endoscopic submucosal dissection)
measure: Prior treatment
timeFrame: At baseline (after informed consent is signed)
measure: Use of symptomatic medication
timeFrame: 2 weeks after endoscopic submucosal dissection
Locations:
Study officials:
References: