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Mucosal Resection System
EndoRotor Resection for Barrett's Esophagus
N/A
Recruiting
Led By Kenneth Wang, MD
Research Sponsored by Interscope, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a new device to treat Barrett's esophagus, a condition where the lining of the esophagus changes. The device is being tested to see if it can remove areas of Barrett's esophagus that haven't responded to other treatments, or if it can be used on patients who can't tolerate other treatments due to pain.
Who is the study for?
This trial is for adults aged 30-90 with Barrett's esophagus and dysplasia who've had at least one failed ablation treatment and can't tolerate more due to pain, or have had three failed treatments. They must not have esophageal cancer, strictures blocking the endoscope, or be on certain blood thinners.Check my eligibility
What is being tested?
The study tests the EndoRotor® system in removing Barrett's esophagus tissue that hasn't responded to at least three prior ablations or when patients couldn't tolerate further ablation. It compares this method to continued standard ablation treatments.See study design
What are the potential side effects?
Potential side effects may include discomfort from repeated endoscopic procedures, risks associated with sedation, bleeding, infection risk post-procedure, and possible short-term swallowing difficulties.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of complete removal of refractory Barrett's esophagus
Rate of device- and procedure-related serious adverse events (SAEs)
Secondary outcome measures
Activated Fibroblasts
Percent Reduction of Barrett's Esophagus
Post Procedure Pain
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EndoRotor ResectionExperimental Treatment1 Intervention
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.
Group II: Continued Ablation (Control)Active Control1 Intervention
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.
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Who is running the clinical trial?
Interscope, Inc.Lead Sponsor
4 Previous Clinical Trials
186 Total Patients Enrolled
Kenneth Wang, MDPrincipal InvestigatorThe Mayo Clinic
6 Previous Clinical Trials
661 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Barrett's esophagus is longer than 6 cm.I have a blood clotting disorder.I have nodular Barrett's esophagus.I am not willing to undergo multiple endoscopies.I have Barrett's esophagus with dysplasia, fit the study's health criteria, and can follow the study for 12 months.My esophageal cancer has been confirmed by a scope or biopsy.I have had swollen veins in my esophagus.My esophagitis is moderate to severe.I have had esophageal surgery, but not fundoplication or it was without complications.My blood pressure cannot be controlled with medication.I have a serious illness and am expected to live less than 2 years.I am between 30 and 90 years old.I cannot stop my blood thinner medication for 5 days around a procedure.I am unable to understand and give consent for my treatment.I have a narrow esophagus that can't be widened, blocking medical instruments.
Research Study Groups:
This trial has the following groups:- Group 1: Continued Ablation (Control)
- Group 2: EndoRotor Resection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a limit to the number of participants in this research project?
"Affirmative. Clinicaltrials.gov confirms that this medical research is currently accepting participants, and was initially posted on February 9th 2018 with the last update occurring on August 1st 2022. The trial requires a total of 120 individuals to be recruited from 2 separate sites."
Answered by AI
Does the age requirement for this trial extend to individuals below thirty years of age?
"This clinical trial is seeking participants between the ages of 30 and 89. Furthermore, there are 1 trials for minors and 36 studies recruiting seniors aged 65+."
Answered by AI
Are there still opportunities to take part in this trial?
"Affirmative. The information found on clinicaltrials.gov implies that this study is actively seeking out candidates, with the initial posting date of February 9th 2018 and most recent edit being August 1st 2022. Subject recruitment for this investigation encompasses 120 people across two sites."
Answered by AI
Am I qualified to take part in this research endeavor?
"To participate in this trial, individuals must have barrett esophagus and be between 30-89 years old. This clinical study is seeking to enrol approximately 120 participants."
Answered by AI
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