Clinical trials: Barrett's Esophagus
Barrett Esophagus
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)
- Trial name
- ColdPlayIII (NCT02514525)
- Testing
- CryoBalloon Ablation System
- Where
- 11 sites in United States
- Volunteers
- 150 people
- Sponsor
- Pentax Medical
Barrett Esophagus, Esophageal Adenocarcinoma
Lucid Registry Study
This is a multicenter, prospective, observational study designed to capture a limited set of data consisting of diagnostic test results and clinical management information on subjects who undergo EC/EG to assess for the presence…
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia
- Trial name
- Lucid Registry (NCT05965999)
- Testing
- EsoCheck®, EsoGuard®
- Where
- United States
- Volunteers
- 8,000 people
- Sponsor
- Lucid Diagnostics, Inc.
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 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
Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System
The NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your…
- Trial name
- DDP (NCT02864043)
- Testing
- NvisionVLE with Real Time Targeting, esophagogastroduodenoscopy (EGD)
- Where
- 5 sites in United States
- Volunteers
- 150 people
- Sponsor
- NinePoint Medical
Barrett's Esophagus
High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)
The primary objective of this clinical trial is to evaluate the performance of the Nvision Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects undergoing esophagogastroduodenoscopy (EGD) and to…
- Trial name
- NCT01503411
- Where
- 3 sites in United States
- Volunteers
- 120 people
- Sponsor
- NinePoint Medical
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'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, Gastroesophageal Reflux
The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. 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…
- Conditions
- Barrett Esophagus, Gastroesophageal Reflux, Esophageal Dysplasia, Esophageal Diseases
- Trial name
- NCT02988934
- Where
- United States
- Volunteers
- 3,173 people
- Sponsor
- CDx Diagnostics
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 Syndrome, Barrett's Syndrome
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).
- Conditions
- Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus
- Trial name
- CLEAN-MARGIN (NCT01032044)
- Testing
- Standard endoscopic evaluation, pCLE guided evaluation
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 164 people
- Sponsor
- Mauna Kea Technologies
Barrett Esophagus
HALO Patient Registry: Ablation of Barrett's Esophagus
The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD).
- Trial name
- NCT00848237
- Testing
- Radiofrequency Ablation (HALO Ablation Systems)
- Where
- United States
- Volunteers
- 5,521 people
- Sponsor
- Medtronic - MITG
Barrett'S-associated Dysplasia, Intramucosal Adenocarcinoma
A Comparison of Volumetric Laser Endomicroscopy (VLE) and Endoscopic Mucosal Resection (EMR) in Patients With Barrett's Dysplasia or Intramucosal Adenocarcinoma
Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the normal squamous mucosa of the distal esophagus into a specialized intestinal mucosa.
- Trial name
- NCT01862666
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- NinePoint Medical
Barrett Esophagus, Esophageal Cancer
Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus
Capsulomics has developed a prognostic assay for patients with diagnosed Barrett's esophagus (BE). This study will measure how gastroenterologists make surveillance and treatment management decisions when presented with different…
- Trial name
- NCT05846971
- Testing
- Educational materials on validated methylation assay
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Capsulomics, Inc.
Barrett Esophagus
Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.
- Trial name
- NCT03097666
- Testing
- C2 CRYOBALLOON SWIPE ABLATION SYSTEM
- Where
- 3 sites in Netherlands
- Volunteers
- 24 people
- Sponsor
- Pentax Medical
Barrett's Esophagus
Barrett's Esophagus - 315 - 3 Way Cross Over
This study evaluates PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue. All patients will have a baseline endoscopy with multiple biopsies.
- Trial name
- NCT00637988
- Testing
- Esomeprazole, Aspirin, Rofecoxib
- Volunteers
- 32 people
- Sponsor
- AstraZeneca
Barrett's Esophagus, High Grade Dysplasia
Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus
The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD) within Barrett's Esophagus (BE).
- Conditions
- Barrett's Esophagus, High Grade Dysplasia, Low Grade Dysplasia
- Trial name
- ICE (NCT00526786)
- Testing
- CryoSpray Ablation System (510(k) NO: K070893)
- Where
- 16 sites in United States
- Volunteers
- 78 people
- Sponsor
- CSA Medical, 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
Ulcerative Colitis, Crohn Disease
Systems Biology of Gastrointestinal and Related Diseases
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…
- Conditions
- Ulcerative Colitis, Crohn Disease, Obesity, Colon Polyp
- Trial name
- NCT05579444
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Viome
GERD, Barrett Esophagus
The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms or undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for participation, but patients…
- Conditions
- GERD, Barrett Esophagus, Low Grade Esophageal Glandular Dysplasia, Esophageal Diseases
- Trial name
- NCT03859557
- Where
- United States
- Volunteers
- 1,032 people
- Sponsor
- CDx Diagnostics