Clinical trials: Barrett's Esophagus (BE)
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 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
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 (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, 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.