trūFreeze® Spray Cryotherapy Patient Registry

Completed

• Conditions: Esophageal Dysplasia; Esophageal Stenosis; Stenosis of Bronchus or Trachea; Barrett Esophagus; Esophageal Neoplasm; Bronchial Neoplasm
• Interventions: Device: truFreeze Spray Cryotherapy

• Registration Number: NCT01802203
• Lead Sponsor: US Endoscopy Group Inc.

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Subjects may be withdrawn prior to this for any of the following reasons: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

Study Timeline

• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-01
• Study Start: 2013-04
• Primary Completion: 2022-01
• Study Completion: 2022-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
truFreeze spray cryotherapy	truFreeze Spray Cryotherapy	truFreeze Spray Cryotherapy administered as routine clinical care

Primary Outcome Measures

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

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

Trial Locations

Locations (16)

Borland-Groover Clinic; 🇺🇸 Jacksonville, Florida, United States

Scripps Green Hosptial; 🇺🇸 La Jolla, California, United States

Ochsner Medical Center; 🇺🇸 Kenner, Louisiana, United States

University of Colorado Denver; 🇺🇸 Denver, Colorado, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hosptial; 🇺🇸 Boston, Massachusetts, United States

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

ProHEALTH Care Associates; 🇺🇸 Lake Success, New York, United States

University of Rochester/Strong Memorial Medical Center; 🇺🇸 Rochester, New York, United States

NYU; 🇺🇸 New York, New York, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Ahuja Medical Center-CWR University Hosptials; 🇺🇸 Beachwood, Ohio, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States