trūFreeze® Spray Cryotherapy Patient Registry

NCT01802203 | Completed

• 1 other identifier: 003
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 16

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.

Conditions

Barrett Esophagus; Esophageal Dysplasia; Esophageal Neoplasm; Esophageal Stenosis; Bronchial Neoplasm; Stenosis of Bronchus or Trachea

Keywords

Barrett esophagus; Esophageal dysplasia; Upper gastrointestinal squamous dysplasia; Esophageal cancer; Endobronchial cancer; Central airway cancer; Central airway precancerous disease; Central airway granulation tissue; Central airway papillomatosis; Central airway sarcoidosis; Central airway tuberculosis; Tracheal stenosis; Bronchial stenosis

Outcome Measures

Primary Outcomes (1)

• Collect efficacy and outcome data related to the use of trūFreeze® spray cryotherapy for treatment of unwanted tissue in the pulmonary and gastrointestinal settings.

  The registry population consists of patients who are being treated using the trūFreeze® spray cryotherapy device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.

  5 years

Secondary Outcomes (1)

• Collect safety data related to the use of trūFreeze® spray cryotherapy for treatment in the pulmonary and gastrointestinal settings.

  5 years

Study Arms (1)

truFreeze spray cryotherapy

truFreeze Spray Cryotherapy administered as routine clinical care

Device: truFreeze Spray Cryotherapy

Interventions

truFreeze Spray Cryotherapy DEVICE

spray cryotherapy

truFreeze spray cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are being treated using the trūFreeze® spray cryotherapy device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal (GI) setting.

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:

• 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
• 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

Sponsors & Collaborators

• US Endoscopy Group Inc.: lead

Study Sites (16)

Scripps Green Hosptial

La Jolla, California, 92037, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

Ochsner Medical Center

Kenner, Louisiana, 70065, United States

Location

University of Maryland

Baltimore, Maryland, 21210, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Massachusetts General Hosptial

Boston, Massachusetts, 02114, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

ProHEALTH Care Associates

Lake Success, New York, 11042, United States

Location

NYU

New York, New York, 10016, United States

Location

University of Rochester/Strong Memorial Medical Center

Rochester, New York, 14642, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Ahuja Medical Center-CWR University Hosptials

Beachwood, Ohio, 44122, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

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MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms; Esophageal Stenosis; Bronchial Neoplasms; Tracheal Diseases; Tracheal Stenosis

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Nicholas Shaheen, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Robert F Browning, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 1, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)