Oesophageal NeoplasmTRACMOTIONNCT06468800
Feasibility and Added Value of the TRACMOTION Device for ESD
A study testing TRACMOTION in people with Oesophageal Neoplasm, run by Erasmus Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Neoplasm
- What is being tested?
- TRACMOTION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for endoscopic submucosal dissection (upper and lower gastrointestinal tract);
- Lesion is accessible with a therapeutic endoscope;
- Written informed consent;
- Age ≥18 years.
Who cannot join
- Coagulopathy (not corrected prior to endoscopic submucosal dissection);
- Participating in a different experimental drug/device trial in the previous 3 months.
About this study
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.
Read the 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
- Being tested
- TRACMOTION
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRACMOTIONDevice
Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device
| Study group | Role | What they receive |
|---|---|---|
| ESD with TRACMOTION | Other | Patients already scheduled for ESD will undergo an ESD procedure with the aid of the TRACMOTION device. Receives: Device: TRACMOTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time
Procedure time of the endoscopic submucosal dissection will be measured from start incision to end incision (in minutes)
Measured: 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)
Measured: 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 (%).
Measured: 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)
Measured: Immediately after endoscopic submucosal dissection
Secondary outcomes (3)
En-bloc rate
The incidence of en-bloc resections in percentages (%)
Measured: Determined Immediately after endoscopic submucosal dissection
R0 rate
The incidence of R0 resections in percentages (%)
Measured: 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 (%)
Measured: During endoscopic submucosal dissection procedure and 2 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal NeoplasmStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arjun D. Koch, MD, PhD, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468800
- Sponsor's protocol ID
- NL87167.078.24
- Acronym
- TRACMOTION
- Status last verified
- Aug 2024
- First submitted
- 11 Jun 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Added Value of the TRACMOTION Device for ESD
- ClinicalTrials.gov ID
- NCT06468800
- Acronym / sponsor ID
- TRACMOTION / NL87167.078.24
- Conditions
- Oesophageal Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESD with TRACMOTION | Other | Device: TRACMOTIONPatients already scheduled for ESD will undergo an ESD procedure with the aid of the TRACMOTION device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for endoscopic submucosal dissection (upper and lower gastrointestinal tract);
- Lesion is accessible with a therapeutic endoscope;
- Written informed consent;
- Age ≥18 years.
Key exclusion criteria (2 listed)
- Coagulopathy (not corrected prior to endoscopic submucosal dissection);
- Participating in a different experimental drug/device trial in the previous 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRACMOTIONPatients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device | Device | ESD with TRACMOTION |
Primary outcome
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)
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)
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 (%).
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)
3 secondary outcomes
En-bloc rate
Time frame: Determined Immediately after endoscopic submucosal dissection
R0 rate
Time frame: Determined during the pathology review (on average 2 weeks after endoscopic submucosal dissection)
Complications after during and after endoscopic submucosal dissection
Time frame: During endoscopic submucosal dissection procedure and 2 weeks after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TRACMOTION in people with Oesophageal Neoplasm, run by Erasmus Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time (time frame: During endoscopic submucosal dissection procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.