Clinical trial NCT01802203: trūFreeze® Spray Cryotherapy Patient Registry
Official title: trūFreeze® Spray Cryotherapy Patient Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: US Endoscopy Group Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 using the spray cryotherapy trūFreeze® device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.

Patients eligible to participate in the registry will have disease and treatment specific data collected throughout therapy and long-term follow-up. Subjects will be considered to have completed the registry when data from the 5 year follow-up visit has been collected. The beginning of the follow-up period commences with the first endoscopic treatment session.

Subjects may be withdrawn prior to this for any of the following reasons:

1. Death, or
2. Lost to Follow-Up, or
3. Withdrawal of consent, or
4. Discontinuation by the investigator. Three attempts at contact using two different methods are required prior to determination that the subject is lost to follow-up. Attempts at contact must be with certified letters OR documented telephone contact.

The registry will utilize electronic case report forms using a web-based platform housed at the University of North Carolina at Chapel Hill. Access to the database will be limited to individuals involved in the research registry and will require a unique user ID and password. All access to the database and web-based application will be encrypted (HTTPS) and electronic systems compliant with applicable privacy and security regulations. To maintain patient confidentiality, all subjects will be assigned a registry identification number, and this will be the only link between subject identity and treatment information. Read-only access will be provided to any personnel who is not an administrator or responsible for data entry.

All data requested on the case report form must be recorded. All missing data must be explained. The system allows sites to directly enter data electronically, however sites are still responsible for ensuring they have source documents that support all data entered electronically that are separate and verifiable. The registry system will maintain an audit trail that captures when electronic entries are changed, what the change was, and who made the change.

The investigators will ensure the capability for inspections of applicable registry-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). The registry will be monitored by the sponsor, and allow auditing by the Institutional Review Board, government regulatory bodies, and University compliance and quality assurance groups of all registry related documents (e.g. source documents, regulatory documents, data collection instruments, registry data, etc.).

Eligibility criteria: 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

Primary outcomes:
measure: Collect efficacy and outcome data related to the use of trūFreeze® spray cryotherapy for treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
timeFrame: 5 years
Secondary outcomes:
measure: Collect safety data related to the use of trūFreeze® spray cryotherapy for treatment in the pulmonary and gastrointestinal settings.
timeFrame: 5 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hosptial
state: California
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Kenner
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hosptial
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lake Success
country: United States
facility: ProHEALTH Care Associates
state: New York
city: New York
country: United States
facility: NYU
state: New York
city: Rochester
country: United States
facility: University of Rochester/Strong Memorial Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Beachwood
country: United States
facility: Ahuja Medical Center-CWR University Hosptials
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Nicholas Shaheen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed National Military Medical Center
name: Robert F Browning, MD
role: PRINCIPAL_INVESTIGATOR
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