Clinical trials: Barrett Esophagus
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 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'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 Esophagus
Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples
This study is looking at cells collected from the esophagus using a diagnostic device called the EndoSign® Cell Collection Device (a sponge on a thread).
- Trial name
- DETECT-ME (NCT06803927)
- Testing
- Barrett's Esophagus Test (LDT)
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Cyted Health 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 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, 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 Esophagus
Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population
This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.
- Trial name
- ASBE (NCT05778851)
- Testing
- EsoGuard result
- Where
- United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Lucid Diagnostics, 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
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
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
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 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, 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 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 Dysplasia
trūFreeze® Spray Cryotherapy Patient Registry
To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
- Conditions
- Barrett Esophagus, Esophageal Dysplasia, Esophageal Neoplasm, Esophageal Stenosis
- Trial name
- NCT01802203
- Testing
- truFreeze Spray Cryotherapy
- Where
- 16 sites in United States
- Volunteers
- 275 people
- Sponsor
- US Endoscopy Group 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
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'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 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