trūFreeze® Spray Cryotherapy Patient Registry

• ClinicalTrials.gov Identifier: NCT01802203
• Recruitment Status: Completed
• First Posted: March 1, 2013
• Last Update Posted: July 25, 2022
• Sponsor: US Endoscopy Group Inc.
• Information provided by (Responsible Party): US Endoscopy Group Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Barrett Esophagus; Esophageal Dysplasia; Esophageal Neoplasm; Esophageal Stenosis; Bronchial Neoplasm; Stenosis of Bronchus or Trachea	Device: truFreeze Spray Cryotherapy

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Subjects may be withdrawn prior to this for any of the following reasons: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

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 275 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: trūFreeze® Spray Cryotherapy Patient Registry
• Study Start Date: April 2013
• Actual Primary Completion Date: January 2022
• Actual Study Completion Date: April 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
truFreeze spray cryotherapy; truFreeze Spray Cryotherapy administered as routine clinical care	Device: truFreeze Spray Cryotherapy; spray cryotherapy

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: 5 years ]
   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 :

1. Collect safety data related to the use of trūFreeze® spray cryotherapy for treatment in the pulmonary and gastrointestinal settings. [ Time Frame: 5 years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

Scripps Green Hosptial

La Jolla, California, United States, 92037

United States, Colorado

University of Colorado Denver

Denver, Colorado, United States, 80045

United States, Florida

Borland-Groover Clinic

Jacksonville, Florida, United States, 32256

United States, Louisiana

Ochsner Medical Center

Kenner, Louisiana, United States, 70065

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21210

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

United States, Massachusetts

Massachusetts General Hosptial

Boston, Massachusetts, United States, 02114

Boston University Medical Center

Boston, Massachusetts, United States, 02118

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, New York

ProHEALTH Care Associates

Lake Success, New York, United States, 11042

NYU

New York, New York, United States, 10016

University of Rochester/Strong Memorial Medical Center

Rochester, New York, United States, 14642

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

United States, Ohio

Ahuja Medical Center-CWR University Hosptials

Beachwood, Ohio, United States, 44122

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

US Endoscopy Group Inc.

Investigators

• Principal Investigator: Nicholas Shaheen, MD; University of North Carolina, Chapel Hill
• Principal Investigator: Robert F Browning, MD; Walter Reed National Military Medical Center

More Information

Additional Information:

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• Responsible Party: US Endoscopy Group Inc.
• ClinicalTrials.gov Identifier: NCT01802203
• Other Study ID Numbers: 003
• First Posted: March 1, 2013
• Last Update Posted: July 25, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by US Endoscopy Group 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:

Neoplasms; Barrett Esophagus; Esophageal Neoplasms; Bronchial Neoplasms; Esophageal Stenosis; Constriction, Pathologic; Pathological Conditions, Anatomical; Precancerous Conditions; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Bronchial Diseases