Status:
COMPLETED
trūFreeze® Spray Cryotherapy Patient Registry
Lead Sponsor:
US Endoscopy Group Inc.
Conditions:
Barrett Esophagus
Esophageal Dysplasia
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
This is a prospective, multi-center registry of patients who are currently undergoing spray cryotherapy using the trūFreeze® device. The registry population consists of patients who are being treated ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT01802203
Start Date
April 1 2013
End Date
April 1 2022
Last Update
July 25 2022
Active Locations (16)
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1
Scripps Green Hosptial
La Jolla, California, United States, 92037
2
University of Colorado Denver
Denver, Colorado, United States, 80045
3
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
4
Ochsner Medical Center
Kenner, Louisiana, United States, 70065