Clinical trials: Barrett Esophagus
Barrett Esophagus
Safety of Photodynamic Therapy (PDT) in the Ablation of High-grade Dysplasia (HGD) in Barrett's Esophagus (BE)
Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a non heated laser. The activation of the drug is done by lighting of abnormal areas using a fiber optic device.
- Trial name
- Oedisse (NCT01209013)
- Testing
- Medlight PDT Balloon, Endoscopy, Endoscopy with biopsy
- Sponsor
- Pinnacle Biologics Inc.
Barrett Esophagus, Esophageal Dysplasia
WATS3D for the Detection of Esophageal Dysplasia
Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies.
- Conditions
- Barrett Esophagus, Esophageal Dysplasia, Esophagus Adenocarcinoma
- Trial name
- NCT03008980
- Testing
- Diagnostic Test
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- CDx Diagnostics
Barrett's Esophagus With Dysplasia
Endorotor Resection In Refractory Barrett's Dysplasia Patients
The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy)…
- Trial name
- NCT03364114
- Testing
- EndoRotor Mucosal Resection System, Continued Ablation
- Where
- 3 sites in United States, Sweden and 1 more
- Volunteers
- 15 people
- Sponsor
- Interscope, Inc.
Barrett's Esophagus, Esophageal Cancer
Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
- Trial name
- NCT01293448
- Testing
- Cryoballoon Ablation
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 21 people
- Sponsor
- Pentax Medical
Barrett's Esophagus
An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients
- Trial name
- NCT00352261
- Testing
- Esomeprazole, Lansoprazole
- Where
- 12 sites in United States
- Volunteers
- 80 people
- Sponsor
- AstraZeneca
Barrett Esophagus, Barretts Esophagus With Dysplasia
CLUE: CLinical Utility Study of EsoGuard
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral.
- Conditions
- Barrett Esophagus, Barretts Esophagus With Dysplasia, Esophagus Adenocarcinoma
- Trial name
- PR-0410 (NCT06030180)
- Testing
- EsoGuard
- Where
- 8 sites in United States
- Volunteers
- 566 people
- Sponsor
- Lucid Diagnostics, Inc.
Barrett's Esophagus, Gastroesophageal Reflux Disease
PillCam® ESO 2 in Esophageal Pathologies
Study Hypothesis: PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting and grading esophagitis.
- Trial name
- MA-76 (NCT00885469)
- Where
- 10 sites in United States
- Volunteers
- 101 people
- Sponsor
- Medtronic - MITG
Barrett Esophagus
C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in ablation naïve patients with low- or high-grade dysplastic Barrett's…
- Trial name
- NCT03311451
- Testing
- C2 CryoBalloon 180° Ablation System
- Where
- 6 sites in Netherlands
- Volunteers
- 62 people
- Sponsor
- Merit Medical Systems, Inc.
Barrett Syndrome, Barrett's Syndrome
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus.
- Conditions
- Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus
- Trial name
- DONTBIOPCE (NCT00795184)
- Testing
- Imaging procedures (NBI), HDWLE, pCLE
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 122 people
- Sponsor
- Mauna Kea Technologies
Gastro-Intestinal Disorder, Barrett Esophagus
Clinical Utility Evidence for TissueCypher®
Cernostics has developed a new diagnostic test, and this study will measure how gastroenterologists and foregut surgeons make diagnostic and treatment decisions when presented with different information in the context of…
- Trial name
- NCT05200325
- Testing
- Educational materials for TissueCypher
- Where
- United States
- Volunteers
- 280 people
- Sponsor
- Qure Healthcare, LLC
Barrett's Esophagus
The Captivator EMR Registry
To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.
- Trial name
- NCT02482701
- Testing
- Captivator™ EMR
- Where
- 13 sites in United States, Belgium and 4 more
- Volunteers
- 291 people
- Sponsor
- Boston Scientific Corporation
Barrett Esophagus, Esophageal Adenocarcinoma
Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and without dysplasia, and/or…
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia
- Trial name
- ESOGUARDBE1 (NCT04293458)
- Testing
- EsoGuard
- Where
- 27 sites in United States, Spain
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Lucid Diagnostics, Inc.
Barrett's Esophagus
Barrett's Esophagus - 315 - 3 Way Cross-Over
This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
- Trial name
- NCT00637559
- Testing
- Esomeprazole Magnesium
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Barrett's Esophagus, Esophageal Cancer
Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.
The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto…
- Trial name
- ESODOI (NCT00754468)
- Testing
- Cryo Spray Ablation
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- CSA Medical, Inc.
Barrett's Esophagus
Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.
- Trial name
- NCT02249975
- Testing
- C2 CryoBalloon Focal Ablation System
- Where
- 2 sites in Netherlands
- Volunteers
- 50 people
- Sponsor
- Pentax Medical
Barrett's Esophagus
The Safety and Tolerability of Secretrol in Patients With Barrett's Esophagus
Secretrol administered over a 6 month period to patients with Barrett's Esophagus will be safe and well tolerated. Further, pH control will be evaluated in the distal esophageal mucosa and just below the squamocolumnar junction.
- Trial name
- NCT01905202
- Testing
- Secretrol
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Effexus Pharmaceutical
Barrett Esophagus
Ablation of Intestinal Metaplasia Containing Dysplasia
The purpose of this study is to determine if the intervention of a 510(k)-cleared endoscopically-guided (Halo Ablation systems), ablation system plus anti-secretory therapy is better than anti-secretory therapy alone in clearing…
- Trial name
- NCT00282672
- Testing
- Ablation System plus anti-secretory medication
- Where
- 19 sites in United States
- Volunteers
- 127 people
- Sponsor
- Medtronic - MITG
Barrett's Esophagus
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
This is a feasibility study without a primary study hypothesis or statistical comparison.
- Trial name
- NCT01633411
- Testing
- Focal Cryoballoon Ablation System - 6 seconds, Focal Cryoballoon Ablation System - 8 seconds, CryoBalloon Focal Ablation System - 10 seconds
- Where
- 8 sites in United States, Netherlands
- Volunteers
- 39 people
- Sponsor
- Pentax Medical
Barrett Esophagus, Esophageal Adenocarcinoma
Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or…
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia
- Trial name
- ESOGUARDBE2 (NCT04295811)
- Testing
- EsoGuard (lab assay), Esophagogastroduodenoscopy
- Where
- 35 sites in United States, Netherlands
- Volunteers
- 784 people, healthy volunteers welcome
- Sponsor
- Lucid Diagnostics, Inc.
Barrett Esophagus
Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years
This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy density (J/cm2) to barrett's tissue.
- Trial name
- AIM (NCT00489268)
- Testing
- HALO Ablation System
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 102 people
- Sponsor
- Covidien, GI Solutions