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trūFreeze® Spray Cryotherapy Patient Registry


N/A
18 Years
N/A
Not Enrolling
Both
Barrett Esophagus, Esophageal Dysplasia, Esophageal Neoplasm, Esophageal Stenosis, Bronchial Neoplasm, Stenosis of Bronchus or Trachea, Central Airway Cancer

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Trial Information

trūFreeze® Spray Cryotherapy Patient Registry


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Subjects may be withdrawn prior to this for any of the following reasons: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


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

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome 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.

Outcome Description:

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.

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CSA-003

NCT ID:

NCT01802203

Start Date:

March 2013

Completion Date:

March 2018

Related Keywords:

  • Barrett Esophagus
  • Esophageal Dysplasia
  • Esophageal Neoplasm
  • Esophageal Stenosis
  • Bronchial Neoplasm
  • Stenosis of Bronchus or Trachea
  • Central Airway Cancer
  • 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
  • Barrett Esophagus
  • Bronchial Neoplasms
  • Neoplasms
  • Constriction, Pathologic
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Esophageal Stenosis

Name

Location

University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Walter Reed National Military Medical CenterBethesda, Maryland  20889