IVLCM tethered capsule for Barrett Esophagus

Phase-Based Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Barrett Esophagus
IVLCM tethered capsule - Device
Eligibility
18+
All Sexes
Eligible conditions
Barrett Esophagus

Study Summary

This study is evaluating whether a new technology can be used to identify people with Barrett's esophagus.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether IVLCM tethered capsule will improve 1 primary outcome in patients with Barrett Esophagus. Measurement will happen over the course of 5 months.

5 months
The number of subjects from which we will be able to collect biopsy samples using IVLCM technique

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
IVLCM tethered capsule for biopsies

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. IVLCM Tethered Capsule is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

IVLCM tethered capsule for biopsies
Device
IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 months for reporting.

Who is running the study

Principal Investigator
G. T.
Guillermo Tearney, Principal Investigator
Massachusetts General Hospital

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients undergoing an EGD with biopsy.
Patients must be over the age of 18.
Patients must be able to give informed consent.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How serious can barrett esophagus be?

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Patients with BE who present early and with few symptoms can safely undergo non-surgical treatment. Patients with more advanced disease and symptoms or other serious comorbidities are likely to qualify for surgical intervention.

Unverified Answer

Can barrett esophagus be cured?

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The effectiveness of managing Barrett's esophagus is limited to preventing it from becoming advanced or cancerous. Although not curable, Barrett's esophagus can be managed successfully with regular endoscopic surveillance and a standard regimen of medications to prevent Barrett's esophagus recurrence.

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What are the common side effects of ivlcm tethered capsule?

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The common side effects of ITCM are nausea and vomiting. Severe side effects occurred <10%; therefore, these side effects are not considered a justification for removing the device. If the side effects are moderate or severe, a doctor may request that all patients return to the clinic for further assessment. The patients need to be informed that severe side effects are <10%. The ITCM can effectively relieve symptoms in some cases. However, most patients require a more complex treatment.

Unverified Answer

What are the signs of barrett esophagus?

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Signs and symptoms of BE include heartburn, esophageal reflux and dysphagia with symptoms worsening with meals and after lying down or lying flat. The diagnosis can only be made by esophageal biopsy. A combination of endoscopy and biopsy is recommended as treatment is ineffective.

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What causes barrett esophagus?

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The majority of patients with BE will not develop esophagitis. In addition to GERD, gastroesophageal reflux, hiatal hernia, and anatomical factors such as hiatus hernia, pyloric ring, and gastroparesis may be contributing to BE. Esophageal dysmotility, or impaired peristalsis, can be a consequence of gastroesophageal reflux and barrett esophagus. Patients with BE must also have regular endoscopies to rule out the possibility that BE could be a cause of dysphagia or other GI symptoms.

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What are common treatments for barrett esophagus?

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Patients diagnosed with Barrett esophagus need supportive care, especially those with oesophageal ulcers. The management of Barrett esophagus is best managed by a gastroenterologist, so patients with Barrett esophagus will be referred urgently for this treatment if diagnosed. There is no cure for Barrett esophagus. However, symptomatic patients will still benefit from specialist oesophageal care.

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What is barrett esophagus?

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Barretts esophagus is a chronic and progressive motility disorder of the esophagus characterized by dilated distal esophageal segments, impaired contractility, and delayed peristaltic waves. Most people with Barrett esophagus develop [esophageal cancer](https://www.withpower.com/clinical-trials/esophageal-cancer). barrett eosophagus is named for William Henry Barrett, an English surgeon known for his descriptions of esophageal dilation and his discovery of the association of the motility disorder with the subsequent development of cancer. The symptoms and risk factors for Barrett esophagus are described herein. The pathophysiology and treatment of Barrett esophagus involve surveillance, prevention of esophageal cancer, and treatment of the motility disorder.

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How many people get barrett esophagus a year in the United States?

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At least 5 million people in the United States have Barrett esophagus, and 1 in 11 patients will have esophageal cancer attributable to Barrett esophagus over 10 years. Thus, as our population ages, more patients need esophageal cancer prevention, and a better understanding of risk factors should help optimize patient outcomes for Barrett esophagus.

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Is ivlcm tethered capsule safe for people?

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Ivlcm capsule has the same safety and efficacy as ivlcm standard capsule, and can be safely used as a less invasive alternative to ivlcm standard capsule.

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How quickly does barrett esophagus spread?

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One in four people with BE have evidence of its presence at the time they are diagnosed with BE. The presence of BE in people at a later date suggests that it may have a slowly progressive course with the greatest risk occurring within the first year.

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What is the latest research for barrett esophagus?

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The pathogenesis of BE seems complex. The research for BE is still under the preliminary stage. But the basic and progress in diagnosing and curing BE can be a way to get the awareness of BE people to raise the understanding of BE from public health viewpoint.

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Have there been any new discoveries for treating barrett esophagus?

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In this issue of the Asian Journal of Gastroenterology, we report the first case of successful use of TENS for Barrett esophagus, thus, demonstrating the potential benefit of this technique in this condition. We hope that this report will help us to further understand the therapeutic potential of TENS in treating gastro-oesophageal reflux disease in Asia. In addition, it will help us to inform physicians about the necessity of and benefits of this non-invasive and inexpensive technique.

Unverified Answer
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