Feasibility and Added Value of the TRACMOTION Device for ESD
NCT Number: NCT06468800
Acronym: TRACMOTION
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oesophageal Neoplasm
Interventions: DEVICE: TRACMOTION
Sponsor: Erasmus Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-03-01

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.

Primary Outcome Measures: Procedure time, Procedure time of the endoscopic submucosal dissection will be measured from start incision to end incision (in minutes), During endoscopic submucosal dissection procedure|Dissection speed, Dissection speed of ESD will be measured from start incision to end incision (square millimeter of dissected tissue per minute), During endoscopic submucosal dissection procedure|Lesional damage, 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 (%)., 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, 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), Immediately after endoscopic submucosal dissection
Secondary Outcome Measures: En-bloc rate, The incidence of en-bloc resections in percentages (%), Determined Immediately after endoscopic submucosal dissection|R0 rate, The incidence of R0 resections in percentages (%), Determined during the pathology review (on average 2 weeks after endoscopic submucosal dissection)|Complications after during and after endoscopic submucosal dissection, Complications will be measured during and after endoscopic submucosal dissection (bleeding yes/no, perforation yes/no) and will be expressed as percentages (%), During endoscopic submucosal dissection procedure and 2 weeks after
Other Outcome Measures: Age, Age in years, At baseline (after informed consent is signed)|Gender, Gender (male/female), At baseline (after informed consent is signed)|Tumor length, Tumor length in millimeter (mm), During endoscopic submucosal dissection, before incision starts|Tumor location, Tumor location in centimeter (cm) measured from incisors, During endoscopic submucosal dissection, before incision starts|Tumor histology, Tumor histology conform the pathology review, After endoscopic submucosal dissection when the pathologist has reviewed the tissue (on average 2 weeks after endoscopic submucosal dissection)|Prior treatment, Prior treatment of oesophageal neoplasms (such as chemotherapy, radiotherapy), At baseline (after informed consent is signed)|Use of symptomatic medication, Use of symptomatic medication during 2 weeks after endoscopic submucosal dissection (analgesics, antiemetics, proton pump inhibitors), 2 weeks after endoscopic submucosal dissection