Barrett EsophagusNCT01802203
trūFreeze® Spray Cryotherapy Patient Registry
An observational study of Barrett Esophagus and Esophageal Dysplasia, run by US Endoscopy Group Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Esophageal Dysplasia, Esophageal Neoplasm
- What is being tested?
- truFreeze Spray Cryotherapy
- Type of treatment
- Medical device
- How many people
- 275 participants
- Where
- 16 sitesUnited States
- Study dates
- Apr 2013to Apr 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Maryland
Baltimore, Maryland, 21210
Ahuja Medical Center-CWR University Hosptials
Beachwood, Ohio, 44122
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Massachusetts General Hosptial
Boston, Massachusetts, 02114
Boston University Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Colorado Denver
Denver, Colorado, 80045
Borland-Groover Clinic
Jacksonville, Florida, 32256
Ochsner Medical Center
Kenner, Louisiana, 70065
Scripps Green Hosptial
La Jolla, California, 92037
ProHEALTH Care Associates
Lake Success, New York, 11042
NYU
New York, New York, 10016
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Rochester/Strong Memorial Medical Center
Rochester, New York, 14642
About this study
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.
Read the 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:
- 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.).
- Conditions
- Barrett Esophagus, Esophageal Dysplasia, Esophageal Neoplasm, Esophageal Stenosis, Bronchial Neoplasm, Stenosis of Bronchus or Trachea
- Being tested
- truFreeze Spray Cryotherapy
- Keywords
- 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
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms, Esophageal Stenosis, Bronchial Neoplasms, Tracheal Diseases, Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
truFreeze Spray CryotherapyDevice
spray cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| truFreeze spray cryotherapy | truFreeze Spray Cryotherapy administered as routine clinical care Receives: Device: truFreeze Spray Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect efficacy and outcome data related to the use of trūFreeze® spray cryotherapy for treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
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.
Measured: 5 years
Secondary outcomes (1)
Collect safety data related to the use of trūFreeze® spray cryotherapy for treatment in the pulmonary and gastrointestinal settings.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- US Endoscopy Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Shaheen, MD, Principal investigator, University of North Carolina, Chapel HillRobert F Browning, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802203
- Sponsor's protocol ID
- 003
- Status last verified
- Jul 2022
- First submitted
- 27 Feb 2013
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
PubMed 22237781Heier SK. Evaluation of candidate therapies for ablation of Barrett's in a canine model. Gastrointestinal endoscopy. 1996;43(4):337
Pasricha PJ, Hill S, Wadwa KS, Gislason GT, Okolo PI 3rd, Magee CA, Canto MI, Kuo WH, Baust JG, Kalloo AN. Endoscopic cryotherapy: experimental results and first clinical use. Gastrointest Endosc. 1999 May;49(5):627-31. doi: 10.1016/s0016-5107(99)70393-7.
PubMed 10228263Greenwald BD, Dumot JA, Horwhat JD, Lightdale CJ, Abrams JA. Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagus. Dis Esophagus. 2010 Jan;23(1):13-9. doi: 10.1111/j.1442-2050.2009.00991.x. Epub 2009 Jun 9.
PubMed 19515183Grana L, Ablin RJ, Goldman S, Milhouse E Jr. Freezing of the esophagus: histological changes and immunological response. Int Surg. 1981 Oct-Dec;66(4):295-301.
PubMed 7345039Loprinzi CL, Foote RL, Michalak J. Alleviation of cytotoxic therapy-induced normal tissue damage. Semin Oncol. 1995 Apr;22(2 Suppl 3):95-7.
PubMed 7740323Rodgers BM, Pappelis P. Profound endoesophageal cryotherapy. Cryobiology. 1985 Feb;22(1):86-92. doi: 10.1016/0011-2240(85)90011-2.
PubMed 3979079Laugier P, Berger G. Assessment of echography as a monitoring technique for cryosurgery. Ultrason Imaging. 1993 Jan;15(1):14-24. doi: 10.1177/016173469301500102.
PubMed 8328116Reiser M, Drukier AK, Ultsch B, Feuerbach S. The use of CT in monitoring cryosurgery. Eur J Radiol. 1983 May;3(2):123-8.
PubMed 6873073Myers B, Donovan W. Cryosurgery of the anus. South Med J. 1977 Jan;70(1):17-8. doi: 10.1097/00007611-197701000-00008.
PubMed 841369McKelvie P. Cryotherapy in the upper air and food passages. Proc R Soc Med. 1975 Oct;68(10):610. doi: 10.1177/003591577506801005. No abstract available.
PubMed 54925Kuflik EG. Cryosurgery updated. J Am Acad Dermatol. 1994 Dec;31(6):925-44; quiz 944-6. doi: 10.1016/s0190-9622(94)70261-6.
PubMed 7962774Rodgers BM, McDonald AP, Talbert JL, Donnelly WH. Morphologic and functional effects of esophageal cryotherapy. J Thorac Cardiovasc Surg. 1979 Apr;77(4):543-9.
PubMed 423587Kantsevoy SV, Cruz-Correa MR, Vaughn CA, Jagannath SB, Pasricha PJ, Kalloo AN. Endoscopic cryotherapy for the treatment of bleeding mucosal vascular lesions of the GI tract: a pilot study. Gastrointest Endosc. 2003 Mar;57(3):403-6. doi: 10.1067/mge.2003.115.
PubMed 12612530Greenwald BD, Dumot JA, Abrams JA, Lightdale CJ, David DS, Nishioka NS, Yachimski P, Johnston MH, Shaheen NJ, Zfass AM, Smith JO, Gill KR, Burdick JS, Mallat D, Wolfsen HC. Endoscopic spray cryotherapy for esophageal cancer: safety and efficacy. Gastrointest Endosc. 2010 Apr;71(4):686-93. doi: 10.1016/j.gie.2010.01.042.
PubMed 20363410
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- trūFreeze® Spray Cryotherapy Patient Registry
- ClinicalTrials.gov ID
- NCT01802203
- Acronym / sponsor ID
- 003
- Conditions
- Barrett Esophagus, Esophageal Dysplasia, Esophageal Neoplasm, Esophageal Stenosis, Bronchial Neoplasm, Stenosis of Bronchus or Trachea
- Keywords
- Barrett esophagus, Esophageal dysplasia, Upper gastrointestinal squamous dysplasia, Esophageal cancer, Endobronchial cancer, Central airway cancer, Central airway precancerous disease, Central airway granulation tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- US Endoscopy Group Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| truFreeze spray cryotherapy | – | Device: truFreeze Spray CryotherapytruFreeze Spray Cryotherapy administered as routine clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- GI conditions include:
- Pulmonary conditions include:
Key exclusion criteria (12 listed)
- Gastrointestinal Exclusion Criteria
- Pulmonary Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| truFreeze Spray Cryotherapyspray cryotherapy | Device | truFreeze spray cryotherapy |
Primary outcome
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.
1 secondary outcome
Collect safety data related to the use of trūFreeze® spray cryotherapy for treatment in the pulmonary and gastrointestinal settings.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Background: PubMed 22237781Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
- BackgroundHeier SK. Evaluation of candidate therapies for ablation of Barrett's in a canine model. Gastrointestinal endoscopy. 1996;43(4):337
- Background: PubMed 10228263Pasricha PJ, Hill S, Wadwa KS, Gislason GT, Okolo PI 3rd, Magee CA, Canto MI, Kuo WH, Baust JG, Kalloo AN. Endoscopic cryotherapy: experimental results and first clinical use. Gastrointest Endosc. 1999 May;49(5):627-31. doi: 10.1016/s0016-5107(99)70393-7.
- Background: PubMed 19515183Greenwald BD, Dumot JA, Horwhat JD, Lightdale CJ, Abrams JA. Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagus. Dis Esophagus. 2010 Jan;23(1):13-9. doi: 10.1111/j.1442-2050.2009.00991.x. Epub 2009 Jun 9.
- Background: PubMed 7345039Grana L, Ablin RJ, Goldman S, Milhouse E Jr. Freezing of the esophagus: histological changes and immunological response. Int Surg. 1981 Oct-Dec;66(4):295-301.
- Background: PubMed 7740323Loprinzi CL, Foote RL, Michalak J. Alleviation of cytotoxic therapy-induced normal tissue damage. Semin Oncol. 1995 Apr;22(2 Suppl 3):95-7.
- Background: PubMed 3979079Rodgers BM, Pappelis P. Profound endoesophageal cryotherapy. Cryobiology. 1985 Feb;22(1):86-92. doi: 10.1016/0011-2240(85)90011-2.
- Background: PubMed 8328116Laugier P, Berger G. Assessment of echography as a monitoring technique for cryosurgery. Ultrason Imaging. 1993 Jan;15(1):14-24. doi: 10.1177/016173469301500102.
- Background: PubMed 6873073Reiser M, Drukier AK, Ultsch B, Feuerbach S. The use of CT in monitoring cryosurgery. Eur J Radiol. 1983 May;3(2):123-8.
- Background: PubMed 841369Myers B, Donovan W. Cryosurgery of the anus. South Med J. 1977 Jan;70(1):17-8. doi: 10.1097/00007611-197701000-00008.
- Background: PubMed 54925McKelvie P. Cryotherapy in the upper air and food passages. Proc R Soc Med. 1975 Oct;68(10):610. doi: 10.1177/003591577506801005. No abstract available.
- Background: PubMed 7962774Kuflik EG. Cryosurgery updated. J Am Acad Dermatol. 1994 Dec;31(6):925-44; quiz 944-6. doi: 10.1016/s0190-9622(94)70261-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Shaheen, MD principal investigator
University of North Carolina, Chapel Hill
Robert F Browning, MD principal investigator
Walter Reed National Military Medical Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus and Esophageal Dysplasia, run by US Endoscopy Group Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01802203, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.