Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468800
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-11
Brief Title:
Feasibility and Added Value of the TRACMOTION Device for ESD
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Feasibility and Added Value of the TRACMOTION Device for ESD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRACMOTION
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
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 parametersendpoints
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
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 parametersendpoints
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None