Barrett's Esophagus With DysplasiaNCT03364114
Endorotor Resection In Refractory Barrett's Dysplasia Patients
A study testing EndoRotor Mucosal Resection System and Continued Ablation in people with Barrett's Esophagus With Dysplasia, run by Interscope, Inc. at 3 sites in 3 countries.
Trial summary
The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are… Read more about this study
- Who is it for?
- Ages 30 to 89 years
- Conditions the study is for
- Barrett's Esophagus With Dysplasia
- What is being tested?
- EndoRotor Mucosal Resection System and Continued Ablation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 9 Feb 2018to 24 Mar 2026
- 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 30 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are greater than 30 and less than 90 years of age; inclusive of males and females.
- Subjects with confirmed Barrett's esophagus with dysplasia (low-grade or high-grade) and meeting at least one of the following criteria:
- Failed 3 ablative procedures (RFA and/or Cryotherapy).
- Failed at least 1 ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-procedure dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.
- Residual Barrett's length is ≥1 cm and ≤6 cm.
- No confirmed evidence of esophageal adenocarcinoma (EAC) at the time of therapy.
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- Subject capable of giving informed consent.
- Subject has a reasonable expectation for prolonged survival (greater than 2 years).
- Subject can tolerate repeated endoscopic procedures.
- Absence of strictures refractory to dilation that preclude the passage of the endoscope
- Patients who were on acid suppression therapy (i.e. PPIs) during the course of failed primary ablative therapy, and who can continue acid suppression therapy for the entire time they are on the clinical study.
- Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 12 months, as indicated.
Who cannot join
- Subject unable to give informed consent.
- Subject is unwilling to return for repeated endoscopies.
- Confirmed endoscopic and or histologic evidence of EAC at time of therapy.
- Residual Barrett's longer than 6 cm.
- Subjects with nodular Barrett's esophagus.
- Subjects who are on anticoagulant therapy that cannot be discontinued for 5 days before and after the procedure.
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- Subjects with known coagulopathy defined as abnormal prothrombin or partial thromboplastin time.
- History of esophageal varices
- LA Grade B, C, or D esophagitis.
- Esophageal stricture refractory to dilation preventing passage of endoscope or catheter.
- Any previous esophageal surgery, except fundoplication without complications.
- Medically uncorrectable hypotension or hypertension.
- Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
- Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
- Subject has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions.
- Patient has a known significant concomitant illness with a life expectancy of less than 2 years.
- Subject is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus
The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.
Read the detailed description
Prospective, multi-center, randomized controlled trial, pivotal, investigational device exemption (IDE) to compare the safety and performance of the EndoRotor® Mucosal Resection System with continued ablative therapy in subjects with refractory Barrett's Esophagus.
The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.
- Conditions
- Barrett's Esophagus With Dysplasia
- Being tested
- EndoRotor Mucosal Resection System, Continued Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoRotor Mucosal Resection SystemDevice
The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.
Continued AblationDevice
Continued ablation control shall include either cryotherapy or continued radial frequency ablation.
| Study group | Role | What they receive |
|---|---|---|
| EndoRotor Resection | Experimental | For the purpose of this study the EndoRotor System is investigationally indicated for use during endoscopic procedures to resect and remove refractory Barrett's esophagus tissue in conjunction with a submucosal saline injection mix using adrenaline and dye. Subjects randomized to the EndoRotor arm will be treated up to 3 times through the 9 month follow-up period to remove gross visible Barrett's. Receives: Device: EndoRotor Mucosal Resection System |
| Continued Ablation (Control) | Active comparator | The investigator shall exercise standard of care for subjects undergoing continued ablative therapies (RFA and/or Cryotherapy). These will constitute the control devices. The investigator will choose the system in this arm. Operation of each system will be done according to the manufacturer's IFU. Subjects randomized to the control arm may be treated up to 3 time through the 9 month follow-up period to remove gross visible Barrett's. Receives: Device: Continued Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete removal of refractory Barrett's esophagus
The primary effectiveness endpoint for this study is the complete removal of refractory Barrett's esophagus in no more than three treatments as assessed by a biopsy negative for Barrett's esophagus at the 12 month follow-up visit.
Measured: 12 months
Rate of device- and procedure-related serious adverse events (SAEs)
The primary safety endpoint for this study is the rate of device- and procedure-related serious adverse events (SAEs) for bleeding, perforation, and stricture in the EndoRotor arm will be no greater than that of the continued ablative therapy arm.
Measured: 12 months
Secondary outcomes (3)
Activated Fibroblasts
Percent reduction of activated fibroblasts in the area with Barrett's esophagus that was resected using EndoRotor at initial treatment session through the 12 month follow-up visit as per the histological findings of keyhole technique biopsies. - this point is only assessed in the first 5 EndoRotor subjects
Measured: 12 months
Percent Reduction of Barrett's Esophagus
Percent reduction of Barrett's esophagus that was resected or ablated during the initial treatment session through the 12 month follow-up visit as calculated using the Prague classification measurements of estimated circumference and maximal length.
Measured: 12 months
Post Procedure Pain
Assessment of subject post procedure pain as compared to the control arm by means of a visual analogue pain scale.
The visual analogue pain scale used for this study allows a patient to record their pain using a scoring system from 0 to 10. Zero representing no pain, 5 representing moderate pain, and 10 representing the worst possible pain. Lower scores represent a better score.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start9 Feb 2018
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Why it stopped: POOR RECRUITMENT
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interscope, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Wang, MD, Principal investigator, The Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364114
- Sponsor's protocol ID
- CLIN-0010
- Status last verified
- Mar 2025
- First submitted
- 29 Nov 2017
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT03364114
- Acronym / sponsor ID
- CLIN-0010
- Conditions
- Barrett's Esophagus With Dysplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: POOR RECRUITMENT
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Interscope, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 6 Dec 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 the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.
Detailed description
Prospective, multi-center, randomized controlled trial, pivotal, investigational device exemption (IDE) to compare the safety and performance of the EndoRotor® Mucosal Resection System with continued ablative therapy in subjects with refractory Barrett's Esophagus.
The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoRotor Resection | Experimental | Device: EndoRotor Mucosal Resection SystemFor the purpose of this study the EndoRotor System is investigationally indicated for use during endoscopic procedures to resect and remove refractory Barrett's esophagus tissue in conjunction with a submucosal saline injection mix using adrenaline and dye. Subjects randomized to the EndoRotor arm will be treated up to 3 times through the 9 month follow-up period to remove gross visible Barrett's. |
| Continued Ablation (Control) | Active comparator | Device: Continued AblationThe investigator shall exercise standard of care for subjects undergoing continued ablative therapies (RFA and/or Cryotherapy). These will constitute the control devices. The investigator will choose the system in this arm. Operation of each system will be done according to the manufacturer's IFU. Subjects randomized to the control arm may be treated up to 3 time through the 9 month follow-up period to remove gross visible Barrett's. |
Who may qualify
- Ages
- 30 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects who are greater than 30 and less than 90 years of age; inclusive of males and females.
- Subjects with confirmed Barrett's esophagus with dysplasia (low-grade or high-grade) and meeting at least one of the following criteria:
- Residual Barrett's length is ≥1 cm and ≤6 cm.
- No confirmed evidence of esophageal adenocarcinoma (EAC) at the time of therapy.
- Subject capable of giving informed consent.
Key exclusion criteria (17 listed)
- Subject unable to give informed consent.
- Subject is unwilling to return for repeated endoscopies.
- Confirmed endoscopic and or histologic evidence of EAC at time of therapy.
- Residual Barrett's longer than 6 cm.
- Subjects with nodular Barrett's esophagus.
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 |
|---|---|---|
| EndoRotor Mucosal Resection SystemThe EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel. | Device | EndoRotor Resection |
| Continued AblationContinued ablation control shall include either cryotherapy or continued radial frequency ablation. | Device | Continued Ablation (Control) |
Primary outcome
Incidence of complete removal of refractory Barrett's esophagus
Time frame: 12 months
The primary effectiveness endpoint for this study is the complete removal of refractory Barrett's esophagus in no more than three treatments as assessed by a biopsy negative for Barrett's esophagus at the 12 month follow-up visit.
Rate of device- and procedure-related serious adverse events (SAEs)
Time frame: 12 months
The primary safety endpoint for this study is the rate of device- and procedure-related serious adverse events (SAEs) for bleeding, perforation, and stricture in the EndoRotor arm will be no greater than that of the continued ablative therapy arm.
3 secondary outcomes
Activated Fibroblasts
Time frame: 12 months
Percent Reduction of Barrett's Esophagus
Time frame: 12 months
Post Procedure Pain
Time frame: 9 months
Results and safety
The study was stopped early (reason given: POOR RECRUITMENT). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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.
Kenneth Wang, MD principal investigator
The Mayo Clinic
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoRotor Mucosal Resection System and Continued Ablation in people with Barrett's Esophagus With Dysplasia, run by Interscope, Inc. at 3 sites in 3 countries.
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 12 inclusion and 17 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: stopped early, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Sweden, United Kingdom. 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 was stopped early (reason given: POOR RECRUITMENT). 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?
Incidence of complete removal of refractory Barrett's esophagus (time frame: 12 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?
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 27 Mar 2026.