trūFreeze® Spray Cryotherapy Patient Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01802203|
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : July 25, 2022
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|Condition or disease||Intervention/treatment|
|Barrett Esophagus Esophageal Dysplasia Esophageal Neoplasm Esophageal Stenosis Bronchial Neoplasm Stenosis of Bronchus or Trachea||Device: truFreeze Spray Cryotherapy|
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Subjects may be withdrawn prior to this for any of the following reasons:
- Death, or
- Lost to Follow-Up, or
- Withdrawal of consent, or
- 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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||275 participants|
|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|
truFreeze spray cryotherapy
truFreeze Spray Cryotherapy administered as routine clinical care
Device: truFreeze Spray Cryotherapy
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
GI conditions include:
- Barrett's Esophagus (BE) with or without dysplasia
- Squamous dysplasia
- Esophageal cancer, any stage
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
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
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802203
|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|
|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|
|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|
|Principal Investigator:||Nicholas Shaheen, MD||University of North Carolina, Chapel Hill|
|Principal Investigator:||Robert F Browning, MD||Walter Reed National Military Medical Center|
|Responsible Party:||US Endoscopy Group Inc.|
|Other Study ID Numbers:||
|First Posted:||March 1, 2013 Key Record Dates|
|Last Update Posted:||July 25, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Upper gastrointestinal squamous dysplasia
Central airway cancer
Central airway precancerous disease
Central airway granulation tissue
Central airway papillomatosis
Central airway sarcoidosis
Central airway tuberculosis
Pathological Conditions, Anatomical
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms