Barretts Esophagus With DysplasiaNCT03120195
EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study
A study testing The EndoRotor® in people with Barretts Esophagus With Dysplasia, run by Foundation for Liver Research at 2 sites in Netherlands.
Trial summary
The aim of this study is to assess the safety and feasibility of the EndoRotor® for the ablation of Barrett's esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barretts Esophagus With Dysplasia
- What is being tested?
- The EndoRotor®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesNetherlands
- Study dates
- 27 Jan 2017to 18 Jun 2019
- 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
- Written informed consent.
- Age equal to or above 18 years (adult).
- Minimum (residual) Barrett's length of 2 cm and a maximum length of 5 cm (C0-5M2-5 according to the Prague classification)
- Scheduled Barrett's ablation for:
- Histologically proven intestinal metaplasia with either high- or low-grade dysplasia in the absence of any visible lesion,
- Residual Barrett's mucosa after complete endoscopic resection (for visible lesions containing HGD or EAC.) (EMR <50% of the circumference)
- Favorable anatomy (e.g. straight esophagus, no previous anti-reflux procedure) that allows performing endoscopic treatment with the EndoRotor®.
Who cannot join
- Presence of a visible lesion suspicious of early esophageal cancer or has a high chance of harboring cancer, or biopsy proven cancer.
- In case of previous EMR: EMR specimen showing deep submucosal invasion (> 500μm), poorly to undifferentiated cancer (G3 or G4), lymphovascular invasion, or positive vertical margins.
- In case of previous EMR: > 50% circumference.
- Any prior endoscopic ablation treatment or dilation for esophageal stenosis.
- Significant esophageal stenosis, preventing the passage of the therapeutic endoscope.
- Evidence of portal hypertension, esophageal varices, etc.
Show all 10Show fewer
- An interval < 6 weeks between EMR and EndoRotor treatment.
- An interval of > 6 months after the last high resolution endoscopy with biopsies containing low or high grade dysplasia.
- Unable to undergo endoscopic procedure using sedation analgesics.
- Anti-coagulant therapy (apart from monotherapy aspirin) that cannot be discontinued prior to the procedure, OR uncorrectable hemostatic disorders.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Radboud University Medical Center
Nijmegen
Erasmus MC, University Medical Center
Rotterdam
About this study
The aim of this study is to assess the safety and feasibility of the EndoRotor® for the ablation of Barrett's esophagus.
Read the detailed description
Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an indication for ablation treatment. These include patients with low grade dysplasia (LGD), high grade dysplasia (HGD) or residual Barrett's after a complete endoscopic resection of a lesion containing HGD or esophageal adenocarcinoma. Ablation treatment will be performed by the EndoRotor ablation device, followed by surveillance endoscopy at 3 months where the feasibility for ablation will be assessed. During the 3 months follow-up, all adverse events such as perforation, post-procedural bleeding, stricture, and pain will be registered.
The EndoRotor® System is in automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it, automatically sending the tissue to a collection trap for histological evaluation.
- Conditions
- Barretts Esophagus With Dysplasia
- Being tested
- The EndoRotor®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The EndoRotor®Device
The EndoRotor® is in automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it, automatically sending the tissue to a collection trap for histological evaluation.
| Study group | Role | What they receive |
|---|---|---|
| EndoRotor® ablation | Experimental | Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an indication for ablation treatment. Barrett's ablation will be performed using the EndoRotor®. Receives: Device: The EndoRotor® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of EndoRotor® ablation of Barrett's mucosa; Number of participants with treatment related adverse events, such as bleeding, perforation or post procedural stenosis
Participants will have follow-up visits after the procedure during which the occurence of adverse events will be assessed. Adverse events will be classified according to the severity and onset timing.
Measured: 3 months
Feasibility of EndoRotor® for the ablation of Barrett's mucosa
The percentage of endoscopically visible surface regression of Barrett's epithelium after 3 months post EndoRotor® treatment
Measured: 3 months
Secondary outcomes (5)
To assess the patient discomfort (recorded using the Numeric Rating Scale - grade 1-10)
The discomfort score will be recorded in a diary during the first 30 days post procedure
Measured: 1 month
To assess the dysphagia-score (recorded using the Ogilvie score)
The dysphasia score will be recorded in a diary during the first 30 days post procedure
Measured: 1 month
To assess a variety of symptoms (recorded using a 7 point Likert scale)
The symptoms will be recorded in a diary during the first 30 days post procedure
Measured: 1 month
Total time to resect tissue
Procedure time is recorded during the EndoRotor® procedure
Measured: Procedure
Ease of performing the EndoRotor® procedure
Procedural performance of the endoscopist will be assessed, using a predefined questionaire.
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start27 Jan 2017
- Primary completion21 Jan 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barretts Esophagus With DysplasiaStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Collaborators
- Interscope, Inc.
- Responsible party
- Sponsor
- Investigators
- Arjun D. Koch, MD, PhD, Principal investigator, Erasmus MC, University Medical Center Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120195
- Sponsor's protocol ID
- 2016-688
- Status last verified
- Jan 2020
- First submitted
- 4 Apr 2017
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gotink AW, Peters Y, Bruno MJ, Siersema PD, Koch AD. Nonthermal resection device for ablation of Barrett's esophagus: a feasibility and safety study. Endoscopy. 2022 Jun;54(6):545-552. doi: 10.1055/a-1644-4326. Epub 2021 Dec 21.
PubMed 34521118
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT03120195
- Acronym / sponsor ID
- 2016-688
- Conditions
- Barretts Esophagus With Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Collaborators
- Interscope, Inc.
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 19 Apr 2017 (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.
The aim of this study is to assess the safety and feasibility of the EndoRotor® for the ablation of Barrett's esophagus.
Detailed description
Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an indication for ablation treatment. These include patients with low grade dysplasia (LGD), high grade dysplasia (HGD) or residual Barrett's after a complete endoscopic resection of a lesion containing HGD or esophageal adenocarcinoma. Ablation treatment will be performed by the EndoRotor ablation device, followed by surveillance endoscopy at 3 months where the feasibility for ablation will be assessed. During the 3 months follow-up, all adverse events such as perforation, post-procedural bleeding, stricture, and pain will be registered.
The EndoRotor® System is in automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it, automatically sending the tissue to a collection trap for histological evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoRotor® ablation | Experimental | Device: The EndoRotor®Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an indication for ablation treatment. Barrett's ablation will be performed using the EndoRotor®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent.
- Age equal to or above 18 years (adult).
- Minimum (residual) Barrett's length of 2 cm and a maximum length of 5 cm (C0-5M2-5 according to the Prague classification)
- Scheduled Barrett's ablation for:
- Favorable anatomy (e.g. straight esophagus, no previous anti-reflux procedure) that allows performing endoscopic treatment with the EndoRotor®.
Key exclusion criteria (10 listed)
- Presence of a visible lesion suspicious of early esophageal cancer or has a high chance of harboring cancer, or biopsy proven cancer.
- In case of previous EMR: EMR specimen showing deep submucosal invasion (> 500μm), poorly to undifferentiated cancer (G3 or G4), lymphovascular invasion, or positive vertical margins.
- In case of previous EMR: > 50% circumference.
- Any prior endoscopic ablation treatment or dilation for esophageal stenosis.
- Significant esophageal stenosis, preventing the passage of the therapeutic endoscope.
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 |
|---|---|---|
| The EndoRotor®The EndoRotor® is in automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it, automatically sending the tissue to a collection trap for histological evaluation. | Device | EndoRotor® ablation |
Primary outcome
Safety of EndoRotor® ablation of Barrett's mucosa; Number of participants with treatment related adverse events, such as bleeding, perforation or post procedural stenosis
Time frame: 3 months
Participants will have follow-up visits after the procedure during which the occurence of adverse events will be assessed. Adverse events will be classified according to the severity and onset timing.
Feasibility of EndoRotor® for the ablation of Barrett's mucosa
Time frame: 3 months
The percentage of endoscopically visible surface regression of Barrett's epithelium after 3 months post EndoRotor® treatment
5 secondary outcomes
To assess the patient discomfort (recorded using the Numeric Rating Scale - grade 1-10)
Time frame: 1 month
To assess the dysphagia-score (recorded using the Ogilvie score)
Time frame: 1 month
To assess a variety of symptoms (recorded using a 7 point Likert scale)
Time frame: 1 month
Total time to resect tissue
Time frame: Procedure
Ease of performing the EndoRotor® procedure
Time frame: Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Derived from this study: PubMed 34521118Gotink AW, Peters Y, Bruno MJ, Siersema PD, Koch AD. Nonthermal resection device for ablation of Barrett's esophagus: a feasibility and safety study. Endoscopy. 2022 Jun;54(6):545-552. doi: 10.1055/a-1644-4326. Epub 2021 Dec 21.
- Individual participant dataSharing planned: No
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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.
Arjun D. Koch, MD, PhD principal investigator
Erasmus MC, University Medical Center Rotterdam
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The EndoRotor® in people with Barretts Esophagus With Dysplasia, run by Foundation for Liver Research at 2 sites in Netherlands.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of EndoRotor® ablation of Barrett's mucosa; Number of participants with treatment related adverse events, such as bleeding, perforation or post procedural stenosis (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120195, which also lists 1 linked publication.
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 29 Jan 2020.