Feasibility and Added Value of the TRACMOTION Device for ESD

NCT ID: NCT06468800

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-03-01

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).

Conditions

Oesophageal Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESD with TRACMOTION

Patients already scheduled for ESD will undergo an ESD procedure with the aid of the TRACMOTION device.

Group Type: OTHER

TRACMOTION

Intervention Type: DEVICE

Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device

Interventions

TRACMOTION

Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Arjun D. Koch, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NL87167.078.24

Identifier Type: -

Identifier Source: org_study_id