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Barrett Esophagus clinical trials

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NCT ID: NCT02422433 Active, not recruiting - Barrett's Esophagus Clinical Trials

Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule

Start date: June 2014
Phase: N/A
Study type: Interventional

The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).

NCT ID: NCT02407392 Recruiting - Barrett Esophagus Clinical Trials

"Using Dilute Vinegar to Find Changes in Cells During Endoscopy for Patients With Barrett's Oesophagus" (The ABBA Study)

ABBA
Start date: July 2015
Phase: N/A
Study type: Interventional

Problem statement Barrett's oesophagus is a pre-cancerous condition affecting 375,000 people in the U.K. There is a 0.5-3% yearly risk of progressing to oesophageal cancer, from which only 5% of patients will survive for 5 years after diagnosis. Diagnosing the disease at the stage of dysplasia (pre-cancerous) and early cancer improves survival. This has led to the current surveillance strategy of gastroscopy with non-targeted mapping biopsies taken from the Barrett's oesophagus every two years. The large number of biopsies required is time consuming and expensive, yet dysplasia and cancerous tissue is still missed due to the non-targeted biopsy sampling strategy. Acetic acid has been used effectively in the early detection of cervical dysplasia and cancer, and has also been used with success in a high risk Barrett's population (patients with suspected dysplasia or previously treated dysplasia), but not been studied in the lower risk Barrett's surveillance population. A diagnostic study of non-targeted mapping biopsies (current practice) versus targeted biopsies (acetic acid) in a surveillance population is needed before widespread adoption of this technique is possible.

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: NCT02395471 Completed - GERD Clinical Trials

Cytosponge Adequacy Study Evaluation II

CASEII
Start date: August 2015
Phase: N/A
Study type: Interventional

This study will assess the Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms.

NCT ID: NCT02366039 Completed - Clinical trials for Early Esophageal Cancer

Probe-based Volumetric Laser Endomicroscopy (pVLE) of Endoscopic Mucosal Resection (EMR) Tissue in Patients With Barrett's Dysplasia

VLE EMR
Start date: September 2014
Phase:
Study type: Observational

This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard histopathology

NCT ID: NCT02310230 Recruiting - Stomach Neoplasms Clinical Trials

An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy

Start date: September 2014
Phase: N/A
Study type: Interventional

Purpose: To assess the utility of a new medical device that monitors a patient's breathing during medical procedures in which a patient is sedated, but not mechanically ventilated. In minor procedures, such as endoscopy (where the doctor examines a patient's digestive tract by a TV camera inserted through the mouth), patients do not require general anesthesia, in which a machine would take over their breathing while they are unconscious for surgery. However, during endoscopic procedures it is sometimes difficult for the anesthesiologist to monitor the patient's breathing—specifically, to monitor changes in breathing patterns and the adequacy of breathing. In endoscopy procedures, the room is darkened, and the patient's mouth is generally occupied by the endoscope. While the anesthesiologist can listen to the patient's breathing sounds with a stethoscope, this type of monitoring can only be done periodically, and there is limited ability to gauge the adequacy of ventilation. This study will use the ExSpiron Respiratory Volume Monitor (RVM), which measures non-invasive minute ventilation (MV), tidal volume (TV) and respiratory rate (RR), in patients undergoing an endoscopic procedure to provide additional information regarding the effects of clinical interventions such as drug administrations or airway maneuvers on the patient's respiratory status. For patients who give informed consent, study participation means that they will have a PadSet consisting of 3 electrodes applied to the chest. Another component, a nasal cannula (a thin clear plastic tube that goes under the nose) will give patients supplemental oxygen, and is standard of care for endoscopy at UVM Medical Center. Patients will then be asked to breathe in and out of a portable spirometer (breath meter) for 30 seconds up to five times. This data will be compared to data recorded by the monitor to confirm that the monitor is recording accurately. The procedure will then go forward in the normal fashion. Patients will be randomly placed into one of two groups. In the first group during the procedure, the anesthesiologist will not be able to see the numbers (MV, TV, and RR) displayed screen of the monitor, so the data will not be used to guide the patient's clinical care. In the second group, the anesthesiologist will be able to see the RVM measurements of MV, TV, and RR to evaluate the effect of the interventions. Monitoring for both groups will continue in the recovery room, until discharge.

NCT ID: NCT02284802 Completed - Clinical trials for Head and Neck Neoplasms

Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy

Start date: September 10, 2014
Phase: N/A
Study type: Interventional

Confocal endomicroscopy is an emerging technique that allows in vivo imaging of cells and tissue structures of the gastrointestinal mucosa, with a magnification of about 1000 times, guiding optical biopsies in real time. Confocal endomicroscopy represents technique that combines conventional white light image with the confocal microscope probe, thereby allowing examination of the surface epithelium in vivo and histological diagnosis during endoscopy. Among the applications already established for its use, stand out diagnosis of Barrett's esophagus, gastric atrophy and intestinal metaplasia, celiac disease, differentiation of hyperplastic adenomatous polyps of the colon, microscopic colitis and follow-up of patients with inflammatory disease, reducing the need for endoscopic biopsies. The CLE can still detect molecular changes effectively improving the endoscopic diagnosis. This pilot project consists of 07 subprojects which the technology of confocal endomicroscopia will be evaluated and compared with the histological results of biopsy or surgical specimens: 1. confocal endomicroscopy for the diagnosis of high-grade dysplasia and superficial esophageal adenocarcinoma in patients with Barrett's esophagus 2 Diagnosis of superficial esophageal squamous cell carcinoma in patients with head and neck cancer by confocal endomicroscopy 3 Detect the presence of premalignant lesions in the gastric stump in patients with reflux alkaline gastritis after partial gastrectomy 4. detect lesions in the gastric mucosa of patients with familial history of gastric cancer 5 Biliary Strictures: differential diagnosis by confocal endomicroscopia 6 confocal Endomicroscopy of cystic neoplasms of the pancreas 7 Contribution of confocal endomicroscopy for the differential diagnosis of colorectal polyps The project aims to deploy the structure of the Confocal endomicroscopy Endoscopy ICESP, for performing in vivo histological examinations of the digestive tract, biliary tract and pancreas. All research groups involved in the early detection of tumors of the esophagus, stomach, biliary tract, pancreas, colon and rectum may benefit from the implementation of this methodology.

NCT ID: NCT02249975 Completed - Barrett's Esophagus Clinical Trials

Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.

NCT ID: NCT02230410 Completed - Barrett's Esophagus Clinical Trials

Cryo Balloon for Residual Barrett's Esophagus

Cryoballoon
Start date: August 2014
Phase: N/A
Study type: Interventional

This study is being done to see if treating residual Barrett's Esophagus after previously having undergone Radiofrequency ablation or Endoscopic Mucosal resection can be eliminated with focal cryotherapy.

NCT ID: NCT02210039 Completed - Barrett's Esophagus Clinical Trials

Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe

Start date: June 2014
Phase: N/A
Study type: Interventional

The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE). Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.