CompletedNot applicableNCT01802203

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

StatusCompleted
PhaseNot applicable
U.S. locations16
SponsorUS Endoscopy Group Inc.
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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