Clinical trials: Barrett's Esophagus With Dysplasia
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'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 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, Esophageal Dysplasia
Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma
This is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia.
- Conditions
- Barrett Esophagus, Esophageal Dysplasia, Esophageal Adenocarcinoma
- Trial name
- NCT03015389
- Testing
- Diagnostic Test
- Where
- Belgium
- Volunteers
- 170 people
- Sponsor
- CDx Diagnostics
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, High-grade Dysplasia in Barrett Esophagus
Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique
Lay summary: Barrett's Esophagus (BE) involves a change of the esophagus lining (BE epithelium) which in a small proportion of patients could be the starting point for the development of cancer (esophageal adenocarcinoma).
- Conditions
- Barrett's Esophagus, High-grade Dysplasia in Barrett Esophagus, Low Grade Dysplasia in Barrett Esophagus
- Trial name
- BURN (NCT03621319)
- Testing
- Hybrid argon plasma ablation (HAPC), Radiofrequency ablation (RFA)
- Where
- 13 sites in United States
- Volunteers
- 41 people
- Sponsor
- Erbe Elektromedizin GmbH
Barrett Esophagus, Gastro Esophageal Reflux
Clinical Utility of WATS3D: A 5-Year Prospective Study
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, Gastro Esophageal Reflux, Esophageal Dysplasia, Esophageal Diseases
- Trial name
- NCT04312633
- Where
- United States
- Volunteers
- 90,000 people
- Sponsor
- CDx Diagnostics
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
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 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 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 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.
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
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
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.