Clinical trials: Barretts Esophagus
Barrett's Esophagus, Esophageal Cancer
CryoSpray Ablation (TM) GI Patient Registry
The purpose of this study is to create a patient registry to collect and analyze post-510K approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.
- Trial name
- NCT00747448
- Where
- 6 sites in United States
- Volunteers
- 199 people
- Sponsor
- CSA Medical, Inc.
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's Esophagus
A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy
The primary objective of this study is to determine the percentage segment regression after spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's Esophagus (BE) using trūFreeze™ spray…
- Trial name
- DOSE (NCT01845454)
- Testing
- trūFreeze™ Spray Cryotherapy
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- CSA Medical, Inc.
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 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 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
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
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 (BE)
Digma System First in Human (FIH) Study
Prospective, open-label, single-arm, early feasibility study (EFS) in 2 Patient cohorts: Cohort A - Dose finding / Dose response study in patients with various etiologies undergoing Esophagectomy and Cohort B - Patients with…
- Trial name
- NCT07331857
- Testing
- Endoscopic Gastrointestinal Ablation Device (EGAD)
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- Digma Medical Ltd.
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.
High-grade Dysplasia in Barrett Esophagus, Non Small Cell Lung Cancer
Efficacy and Safety of a Sunscreen Against Porfimer Sodium-induced Phototoxicity to Visible Light
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 illuminating abnormal areas using a fiber optic device.
- Conditions
- High-grade Dysplasia in Barrett Esophagus, Non Small Cell Lung Cancer, Esophageal Cancer
- Trial name
- NCT01256203
- Testing
- Solar Protection Formula SPF® 60, Photobiological testing
- Sponsor
- Pinnacle Biologics Inc.
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
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, 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
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.
Esophageal Cancer, Lung Cancer
Case Analysis on Real Life Incidence of Photodynamic Therapy (PDT) Safety Outcomes
Three main adverse reactions, namely photosensitivity (reaction that is similar to sunburn), oesophageal stenosis (narrowing or closure of the food pipe), perforation of the treated area (a tear or puncture of the tissue), have…
- Conditions
- Esophageal Cancer, Lung Cancer, Barrett's Esophagus
- Trial name
- CALIPSO (NCT01203163)
- 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
YF476 in Barrett's Esophagus
A phase 2, randomised, double-blind, out-patient trial to determine if YF476 is a safe and effective treatment in patients with Barrett's esophagus.
- Trial name
- NCT02597712
- Testing
- YF476
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 27 people
- Sponsor
- Trio Medicines Ltd.
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