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.
Checked against the public recordLast updated Jul 25, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- US Endoscopy Group Inc.
- Interventions being studied
- Device: truFreeze Spray Cryotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. GI conditions include: * Barrett's Esophagus (BE) with or without dysplasia * Squamous dysplasia * Esophageal cancer, any stage 2. Pulmonary conditions include: * Any endobronchial cancerous or precancerous disease located within the central airways * Any non-malignant endobronchial process of the central airways that results in abnormal mucosa (i.e. granulation tissue, papillomatosis, sarcoidosis, tuberculosis, etc.) * Tracheal or bronchial stenosis (malignant or benign) * Any pleural disease, malignant or benign All subjects are required to be able to provide written informed consent Exclusion Criteria: 1. Gastrointestinal Exclusion Criteria * Contraindication to spray cryotherapy. * Prior treatment with spray cryotherapy. Previous or concurrent treatment using other mucosal therapies such as endoscopic mucosal resection or radiofrequency ablation is acceptable. * Below 18 years of age 2. Pulmonary Exclusion Criteria * Contraindication to spray cryotherapy. * Prior treatment with spray cryotherapy. Previous or concurrent treatment using other mucosal therapies is acceptable. * Tracheoesophageal fistula. * Bronchopleural fistula. * Current untreated pneumothorax. * Clinically significant hypoxia refractory to supplemental oxygen therapy. * Below 18 years of age
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Scripps Green HosptialLa Jolla, California
- University of Colorado DenverDenver, Colorado
- Borland-Groover ClinicJacksonville, Florida
- Ochsner Medical CenterKenner, Louisiana
- University of MarylandBaltimore, Maryland
- Walter Reed National Military Medical CenterBethesda, Maryland
- Massachusetts General HosptialBoston, Massachusetts
- Boston University Medical CenterBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- ProHEALTH Care AssociatesLake Success, New York
- NYUNew York, New York
- University of Rochester/Strong Memorial Medical CenterRochester, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 25, 2022. Always confirm current availability with the study team.