Clinical trials: Barretts Esophagus
Barrett's Esophagus
Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation
This study is designed to evaluate the effect of dexlansoprazole once daily (QD) and twice daily (BID) dosing on the recurrence of intestinal metaplasia (IM) in participants who achieved complete eradication of Barrett's…
- Trial name
- NCT02162758
- Testing
- Dexlansoprazole
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Takeda
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'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'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
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, 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
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 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
Barrett's Esophagus, GERD
Cytosponge Adequacy Study Evaluation II
This study will assess the Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms.
- Trial name
- CASEII (NCT02395471)
- Testing
- Cytosponge™ Cell Collection Device
- Where
- 5 sites in United States
- Volunteers
- 191 people, healthy volunteers welcome
- 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, 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, 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.
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, 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
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.
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, 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