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Barrett Esophagus clinical trials

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NCT ID: NCT05579444 Terminated - Obesity Clinical Trials

Systems Biology of Gastrointestinal and Related Diseases

Start date: November 11, 2022
Phase:
Study type: Observational

This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.

NCT ID: NCT04642690 Terminated - Barrett Esophagus Clinical Trials

Nitrates and IL-8 in Barrett's Esophagus

Start date: September 24, 2020
Phase:
Study type: Observational

The purpose of this study is to determine if nitrates and IL-8 (which are found in food and throughout the body regulating stomach acidity) play a role in Barrett's Esophagus and/or Esophageal Adenocarcinoma severity and if screening for these biomarkers can help predict patients that are more at risk for developing worsening disease.

NCT ID: NCT03852576 Terminated - Barrett Esophagus Clinical Trials

Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus

Start date: May 9, 2019
Phase: Phase 1
Study type: Interventional

The overall aim of this feasibility study is to develop new technologies for improved detection of Barrett's neoplasia using the scanning fiber endoscope (SFE) imaging system. This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically to pre-cancerous mucosa in the esophagus for use as a novel imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets, including EGFR and HER2, that are specific for esophageal dysplasia. A dimer is needed because cancer in the esophagus is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.

NCT ID: NCT03621319 Terminated - Barrett's Esophagus Clinical Trials

Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique

BURN
Start date: July 24, 2019
Phase: N/A
Study type: Interventional

Lay summary: Barrett's Esophagus (BE) involves a change of the esophagus lining (BE epithelium) which in a small proportion of patients could be the starting point for the development of cancer (esophageal adenocarcinoma). Currently, there is evidence that this change is initiated by acid reflux from the stomach which then could progress in a stepwise manner from the healthy epithelium to cellular changes (intestinal metaplasia, low-grade and high-grade dysplasia) and finally to adenocarcinoma. Surgery is considered the standard therapy for this cancer which involves the risk of death and complications with quality of life impairments. New possibilities for treatment have evolved with endoscopic therapies which allow for treatment of early changes of the epithelium (intestinal metaplasia and dysplasia) prior to the occurrence of cancer using either argon plasma coagulation (APC) or radiofrequency ablation (RFA). Both are established methods for eradication of BE by thermal ablation of the BE epithelium using high frequency current (HF). More advanced BE epithelium with early visible cancers are being treated by endoscopic mucosal resection (EMR). After EMR the residual Barrett's epithelium can also be removed by ablation with RFA or APC. Currently radiofrequency ablation (RFA) has been suggested as the standard therapy for BE treatment. Although effective in the eradication of the BE epithelium after RFA treatment the re-appearance of BE epithelium and the occurrence of complications such as strictures causing swallowing impairments for food have also been observed in clinical studies. A recently developed method is Hybrid argon plasma coagulation (ablation) [HybridAPC® (HAPC)] which combines argon plasma coagulation (APC) with a fluid injection function by a water beam. The water beam allows to establish a fluid cushion (normal sterile saline) right beneath the BE-epithelium prior to thermal ablation thereby protecting the esophagus wall from heat during ablation of epithelium with APC. The goal of this randomized controlled study is to investigate if HAPC is non-inferior to RFA in the stricture-free eradication of the dysplastic BE epithelium.

NCT ID: NCT03417570 Terminated - Barrett Esophagus Clinical Trials

Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study

Start date: December 22, 2017
Phase: N/A
Study type: Interventional

The hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus, the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted endoscopy with that of conventional endoscopy using high definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI) in patients with Barrett's esophagus.

NCT ID: NCT03240679 Terminated - Clinical trials for Barrett Adenocarcinoma

Endoscopic Mucosal Resection and Cellular Matrix

Start date: March 22, 2017
Phase: N/A
Study type: Interventional

This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus.

NCT ID: NCT02988934 Terminated - Clinical trials for Gastroesophageal Reflux

The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry

Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach.). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus. By recording the results of all of your biopsies over many years, it may be possible to find out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and which patients with Barrett's esophagus develop precancer and cancer. The data from your biopsies will be used to determine the best way to diagnose esophageal disease. You are being asked to participate in the study because you are receiving an upper endoscopy (a procedure where a tube with a light and camera are inserted in your mouth and down your throat) with forceps and brush biopsies of your esophagus as part of your standard clinical care, and you are between the ages of 18 and 80.

NCT ID: NCT02614703 Terminated - Barrett's Esophagus Clinical Trials

"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

Start date: March 10, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Neoplasia in Barrett's esophagus could be missed during routine random biopsies. We propose a study using chromoendoscopy with Acetic Acid to increase the yield of biopsies in detecting neoplasia.

NCT ID: NCT02396745 Terminated - Barrett Esophagus Clinical Trials

TECR & ECM Placement for Esophageal High Grade Dysplasia

Start date: January 25, 2016
Phase: N/A
Study type: Interventional

This study will test the safety and effectiveness of esophageal transoral endoscopic circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential resection using ECM placement has been introduced as a less invasive, externally incision-less approach to treat patients with esophageal high grade dysplasia; a pre-cancerous condition. In this procedure, the entire length of diseased (abnormal) mucosa (esophagus lining) will be removed using an endoscope that will be inserted through the mouth. The ECM will be placed over the area that is being removed with a temporary, expandable stent to prevent narrowing of the esophagus. The stent is being used to hold the ECM in place as the body begins the healing process. This stent will be removed 14 days (±4 days) after this procedure. Follow-up esophagogastroduodenoscopies (EGD), barium swallow x-ray tests, and questionnaires will take place for 12 months following the procedure. The result of this study may help doctors determine if this procedure would be a more effective treatment option for HGD in the future.

NCT ID: NCT02162758 Terminated - Barrett's Esophagus Clinical Trials

Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation

Start date: July 2014
Phase: Phase 4
Study type: Interventional

This study is designed to evaluate the effect of dexlansoprazole QD and BID dosing on the recurrence of intestinal metaplasia (IM) in subjects who achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).