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NCT Number: NCT06468800

Feasibility and Added Value of the TRACMOTION Device for ESD

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.

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Key information

Conditions

Oesophageal Neoplasm Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRACMOTION

Device

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

Primary outcomes

  1. Procedure time

    Time frame: During endoscopic submucosal dissection procedure

    Procedure time of the endoscopic submucosal dissection will be measured from start incision to end incision (in minutes)

  2. Dissection speed

    Time frame: During endoscopic submucosal dissection procedure

    Dissection speed of ESD will be measured from start incision to end incision (square millimeter of dissected tissue per minute)

  3. Lesional damage

    Time frame: During endoscopic submucosal dissection and during pathology review (on average 2 weeks after endoscopic submucosal dissection)

    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 (%).

  4. Subjective evaluation of the added value of the TRACMOTION device

    Time frame: Immediately after endoscopic submucosal dissection

    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)

Secondary outcomes

  1. En-bloc rate

    Time frame: Determined Immediately after endoscopic submucosal dissection

    The incidence of en-bloc resections in percentages (%)

  2. R0 rate

    Time frame: Determined during the pathology review (on average 2 weeks after endoscopic submucosal dissection)

    The incidence of R0 resections in percentages (%)

  3. Complications after during and after endoscopic submucosal dissection

    Time frame: During endoscopic submucosal dissection procedure and 2 weeks after

    Complications will be measured during and after endoscopic submucosal dissection (bleeding yes/no, perforation yes/no) and will be expressed as percentages (%)

Other outcomes

  1. Age

    Time frame: At baseline (after informed consent is signed)

    Age in years

  2. Gender

    Time frame: At baseline (after informed consent is signed)

    Gender (male/female)

  3. Tumor length

    Time frame: During endoscopic submucosal dissection, before incision starts

    Tumor length in millimeter (mm)

  4. Tumor location

    Time frame: During endoscopic submucosal dissection, before incision starts

    Tumor location in centimeter (cm) measured from incisors

  5. Tumor histology

    Time frame: After endoscopic submucosal dissection when the pathologist has reviewed the tissue (on average 2 weeks after endoscopic submucosal dissection)

    Tumor histology conform the pathology review

  6. Prior treatment

    Time frame: At baseline (after informed consent is signed)

    Prior treatment of oesophageal neoplasms (such as chemotherapy, radiotherapy)

  7. Use of symptomatic medication

    Time frame: 2 weeks after endoscopic submucosal dissection

    Use of symptomatic medication during 2 weeks after endoscopic submucosal dissection (analgesics, antiemetics, proton pump inhibitors)

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: TRACMOTION

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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