trūFreeze® Spray Cryotherapy Patient Registry

This study is currently recruiting participants.
Verified March 2014 by CSA Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01802203
First received: February 27, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Barrett Esophagus
Esophageal Dysplasia
Esophageal Neoplasm
Esophageal Stenosis
Bronchial Neoplasm
Stenosis of Bronchus or Trachea
Central Airway Cancer
Device: truFreeze™ Spray Cryotherapy System

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: trūFreeze® Spray Cryotherapy Patient Registry

Resource links provided by NLM:


Further study details as provided by CSA Medical, Inc.:

Primary Outcome Measures:
  • Collect efficacy and outcome data related to the use of trūFreeze® spray cryotherapy for treatment of unwanted tissue in the pulmonary and gastrointestinal settings. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Collect safety data related to the use of trūFreeze® spray cryotherapy for treatment in the pulmonary and gastrointestinal settings. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    All adverse events occurring during the registry period must be recorded. The clinical course of each event should be followed until resolution, stabilization, or until it has been determined that the registry treatment or participation is not the cause. Serious adverse events that are still ongoing at the end of the Spray Cryotherapy Patient Registry registry period must be followed up to determine the final outcome. Any serious adverse event that occurs after the registry period and is considered to be possibly related to the trūFreeze® spray cryotherapy device or registry participation should be recorded and reported immediately.


Estimated Enrollment: 1000
Study Start Date: April 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
trūFreeze® spray cryotherapy
Patients treated using the trūFreeze® spray cryotherapy device for the removal of unwanted tissue for conditions in the gastrointestinal and pulmonary setting.
Device: truFreeze™ Spray Cryotherapy System

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802203

Locations
United States, California
Scripps Green Hosptial Recruiting
La Jolla, California, United States, 92037
Contact: Franklin Tsai, MD    858-554-8880    Tsai.Franklin@scrippshealth.org   
Contact: Walter Coyle, MD    858-554-8880    Coyle.Walter@scrippshealth.org   
Principal Investigator: Franklin Tsai, MD         
Sub-Investigator: Walter Coyle, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21210
Contact: Bruce Greenwald, MD    410-328-8731    bgreenwa@midicine.umaryland.edu   
Contact: Ashutosh Sachdeva, MBBS    410-328-8141    asachdeva@medicine.umaryland.edu   
Principal Investigator: Bruce Greenwald, MD         
Sub-Investigator: Ashutosh Sachdeva, MBBS         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Robert Browning, MD    301-295-4233    robert.browningjr@med.navy.mil   
Principal Investigator: Robert Browning, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Susan Moist, MS    919-843-2508    susan_moist@med.unc.edu   
Principal Investigator: Nicholas J Shaheen, MD, MPH         
United States, Ohio
Ahuja Medical Center-CWR University Hosptials Recruiting
Beachwood, Ohio, United States, 44122
Contact: Lisa Stuart, RN    216-593-1325    Lisa.Stuart@UHhospitals.org   
Principal Investigator: John Dumot, DO         
United States, Pennsylvania
Temple University Health System Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Marian DeBacker, BSN    215-707-7143    Marian.DeBacker@tuhs.temple.edu   
Principal Investigator: Abbas Abbas, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jan Clark, RN    401-444-7344    JClark3@Lifespan.org   
Principal Investigator: Fadlallah Habr, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Brenda Hoffman, MD    843-876-4265    hoffmanb@musc.edu   
Contact: April Wood    843-876-4718      
Principal Investigator: Brenda Hoffman, MD         
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
Principal Investigator: Nicholas Shaheen, MD University of North Carolina, Chapel Hill
Study Director: Ellen Sheets, MD CSA Medical, Inc.
  More Information

Publications:
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA: A Cancer Journal for Clinicians. 2012;62(1):10-29.
Greenwald BD, Dumot J a, Abrams J a, et al. Endoscopic spray cryotherapy for esophageal cancer: safety and efficacy. Gastrointestinal endoscopy. 2010;71(4):686-93
Fernando HC, Dekeratry D, Downie G, et al. Feasibility of spray cryotherapy and balloon dilation for non-malignant strictures of the airway. European journal of cardio-thoracic surgery . 2011;40(5):1177-80

Responsible Party: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT01802203     History of Changes
Other Study ID Numbers: CSA-003
Study First Received: February 27, 2013
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by CSA Medical, Inc.:
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

Additional relevant MeSH terms:
Barrett Esophagus
Bronchial Neoplasms
Neoplasms
Constriction, Pathologic
Esophageal Neoplasms
Esophageal Stenosis
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Bronchial Diseases
Respiratory Tract Diseases
Pathological Conditions, Anatomical
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014