Feasibility and Added Value of the TRACMOTION Device for ESD (TRACMOTION)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Oesophageal Neoplasm
• Intervention / Treatment: Device: TRACMOTION

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).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ESD with TRACMOTION; Patients already scheduled for ESD will undergo an ESD procedure with the aid of the TRACMOTION device.	Device: TRACMOTION; Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: NL87167.078.24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No