Barrett's Esophagus Clinical Trial
Official title:
Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus
The specific aim of this study is to determine the feasibility of marking target pathologic locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of biopsy.
Twenty four consenting patients undergoing esophagogastroduodenoscopy (EGD) surveillance
following a confirmed diagnosis of Barrett's esophagus will be recruited at Massachusetts
General Hospital (MGH) . Along with Optical Frequency Domain Imaging (OFDI) imaging and
cautery marking for targeted biopsy, the patients will undergo a standard of care clinical
Esophagogastroduodenoscopy (EGD) procedure including endoscopic random biopsy. This study
requires the use of a balloon catheter which is a commonly used technique and is accepted in
clinical practice for dilation of esophageal and colonic strictures and for photodynamic
therapy.
Once in position, the OFDI tissue marking laser will be activated by the physician. The
physician will control the marking and make two marks of a duration of 2 seconds each. The 2
seconds time period will limit the tissue effects to only the superficial layers of the
esophageal mucosa.
It is expected that the total experimental time including insertion and inflation of the OFDI
balloon catheter, OFDI imaging, tissue marking, and removal of the OFDI balloon will add
approximately 15 minutes to the total length of the EGD.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02864043 -
Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System
|
N/A | |
| Recruiting |
NCT02018367 -
Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma
|
Phase 2 | |
| Terminated |
NCT01572987 -
Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus
|
N/A | |
| Terminated |
NCT01976351 -
Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus
|
N/A | |
| Terminated |
NCT00526786 -
Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus
|
Phase 4 | |
| Completed |
NCT01401699 -
Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction
|
N/A | |
| Completed |
NCT02106910 -
Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy
|
N/A | |
| Suspended |
NCT01580631 -
Narrow Band Imaging Project on Barrett's Esophagus
|
||
| Completed |
NCT02879721 -
Expression and Function of the Renin-Angiotensin System in the Esophagus
|
Phase 0 | |
| Completed |
NCT01281618 -
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
|
N/A | |
| Completed |
NCT01439594 -
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
|
N/A | |
| Completed |
NCT00844077 -
Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus
|
N/A | |
| Completed |
NCT00586872 -
Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
|
||
| Completed |
NCT00588575 -
Ramanspectroscopy in Barrett's Esophagus
|
||
| Recruiting |
NCT00288119 -
Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
|
||
| Completed |
NCT03813381 -
CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO).
|
N/A | |
| Completed |
NCT02579460 -
Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition
|
N/A | |
| Completed |
NCT01961778 -
Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma
|
N/A | |
| Not yet recruiting |
NCT02033070 -
Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System
|
N/A | |
| Completed |
NCT01733147 -
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids
|
Phase 4 |