trūFreeze® Spray Cryotherapy Patient Registry

Completed

Conditions studied: Barrett Esophagus, Esophageal Dysplasia, Esophageal Neoplasm, Esophageal Stenosis, Bronchial Neoplasm, Stenosis of Bronchus or Trachea

In brief

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.

Key facts

Study ID

NCT01802203

Run by

US Endoscopy Group Inc.

People needed

275

Starts

2013-04-01

Expected to finish

2022-04-01

Last updated by the study team

2022-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• GI conditions include:
• Barrett's Esophagus (BE) with or without dysplasia
• Squamous dysplasia
• Esophageal cancer, any stage
• 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

You may not qualify if…

• 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
• 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

Where it is running

• Scripps Green Hosptial — La Jolla, California, United States
• University of Colorado Denver — Denver, Colorado, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Ochsner Medical Center — Kenner, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Massachusetts General Hosptial — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• ProHEALTH Care Associates — Lake Success, New York, United States
• NYU — New York, New York, United States
• University of Rochester/Strong Memorial Medical Center — Rochester, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Ahuja Medical Center-CWR University Hosptials — Beachwood, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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