Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
275 participants
Study Classification
OBSERVATIONAL
Study Start Date
2013-04-30
Study Completion Date
2022-04-30
Brief Summary
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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.
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Detailed Description
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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Subjects may be withdrawn prior to this for any of the following reasons: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.).
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.).
Conditions
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Barrett Esophagus
Esophageal Dysplasia
Esophageal Neoplasm
Esophageal Stenosis
Bronchial Neoplasm
Stenosis of Bronchus or Trachea
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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truFreeze spray cryotherapy
truFreeze Spray Cryotherapy administered as routine clinical care
truFreeze Spray Cryotherapy
Intervention Type
DEVICE
spray cryotherapy
Interventions
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truFreeze Spray Cryotherapy
spray cryotherapy
Intervention Type
DEVICE
Eligibility Criteria
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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
* 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
* 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
* 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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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US Endoscopy Group Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Nicholas Shaheen, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Robert F Browning, MD
Role: PRINCIPAL_INVESTIGATOR
Walter Reed National Military Medical Center
Locations
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Scripps Green Hosptial
La Jolla, California, United States
Site Status
University of Colorado Denver
Denver, Colorado, United States
Site Status
Borland-Groover Clinic
Jacksonville, Florida, United States
Site Status
Ochsner Medical Center
Kenner, Louisiana, United States
Site Status
University of Maryland
Baltimore, Maryland, United States
Site Status
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Site Status
Massachusetts General Hosptial
Boston, Massachusetts, United States
Site Status
Boston University Medical Center
Boston, Massachusetts, United States
Site Status
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Site Status
ProHEALTH Care Associates
Lake Success, New York, United States
Site Status
NYU
New York, New York, United States
Site Status
University of Rochester/Strong Memorial Medical Center
Rochester, New York, United States
Site Status
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Site Status
Ahuja Medical Center-CWR University Hosptials
Beachwood, Ohio, United States
Site Status
Rhode Island Hospital
Providence, Rhode Island, United States
Site Status
Medical University of South Carolina
Charleston, South Carolina, United States
Site Status
Countries
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United States
References
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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.
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Heier SK. Evaluation of candidate therapies for ablation of Barrett's in a canine model. Gastrointestinal endoscopy. 1996;43(4):337
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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.
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Greenwald 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.
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Grana 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.
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Loprinzi CL, Foote RL, Michalak J. Alleviation of cytotoxic therapy-induced normal tissue damage. Semin Oncol. 1995 Apr;22(2 Suppl 3):95-7.
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Rodgers BM, Pappelis P. Profound endoesophageal cryotherapy. Cryobiology. 1985 Feb;22(1):86-92. doi: 10.1016/0011-2240(85)90011-2.
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Laugier P, Berger G. Assessment of echography as a monitoring technique for cryosurgery. Ultrason Imaging. 1993 Jan;15(1):14-24. doi: 10.1177/016173469301500102.
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Reiser M, Drukier AK, Ultsch B, Feuerbach S. The use of CT in monitoring cryosurgery. Eur J Radiol. 1983 May;3(2):123-8.
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Myers B, Donovan W. Cryosurgery of the anus. South Med J. 1977 Jan;70(1):17-8. doi: 10.1097/00007611-197701000-00008.
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McKelvie 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.
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Kuflik EG. Cryosurgery updated. J Am Acad Dermatol. 1994 Dec;31(6):925-44; quiz 944-6. doi: 10.1016/s0190-9622(94)70261-6.
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Rodgers BM, McDonald AP, Talbert JL, Donnelly WH. Morphologic and functional effects of esophageal cryotherapy. J Thorac Cardiovasc Surg. 1979 Apr;77(4):543-9.
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Kantsevoy 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.
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BACKGROUND
Greenwald 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.
Reference Type
BACKGROUND
Dumot JA, Vargo JJ 2nd, Falk GW, Frey L, Lopez R, Rice TW. An open-label, prospective trial of cryospray ablation for Barrett's esophagus high-grade dysplasia and early esophageal cancer in high-risk patients. Gastrointest Endosc. 2009 Oct;70(4):635-44. doi: 10.1016/j.gie.2009.02.006. Epub 2009 Jun 25.
Reference Type
BACKGROUND
Finley DJ, Dycoco J, Sarkar S, Krimsky WS, Sherwood JT, Dekeratry D, Downie G, Atwood J, Fernando HC, Rusch VW. Airway spray cryotherapy: initial outcomes from a multiinstitutional registry. Ann Thorac Surg. 2012 Jul;94(1):199-203; discussion 203-4. doi: 10.1016/j.athoracsur.2012.01.112. Epub 2012 Apr 18.
Reference Type
BACKGROUND
Au JT, Carson J, Monette S, Finley DJ. Spray cryotherapy is effective for bronchoscopic, endoscopic and open ablation of thoracic tissues. Interact Cardiovasc Thorac Surg. 2012 Oct;15(4):580-4. doi: 10.1093/icvts/ivs192. Epub 2012 Jul 18.
Reference Type
BACKGROUND
Krimsky WS, Rodrigues MP, Malayaman N, Sarkar S. Spray cryotherapy for the treatment of glottic and subglottic stenosis. Laryngoscope. 2010 Mar;120(3):473-7. doi: 10.1002/lary.20794.
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Fernando HC, Dekeratry D, Downie G, Finley D, Sullivan V, Sarkar S, Rivas R Jr, Santos RS. Feasibility of spray cryotherapy and balloon dilation for non-malignant strictures of the airway. Eur J Cardiothorac Surg. 2011 Nov;40(5):1177-80. doi: 10.1016/j.ejcts.2011.02.062. Epub 2011 Apr 8.
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Evantash E, Hill EC, Pernoll ML. Benign disorders of the uterine cervix. Current Obstetric& Gynecologic, Diagnosis & Treatment. 9th ed. Beijing: The McGraw-Hill Companies. 2003:677-692
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Holschneider CH. Premalignant and malignant disorders of the uterine cervix. Current Diagnosis and Treatment Obstetrics and Gynecology,. 2007:833-854
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BACKGROUND
Jacob M, Broekhuizen FF, Castro W, Sellors J. Experience using cryotherapy for treatment of cervical precancerous lesions in low-resource settings. Int J Gynaecol Obstet. 2005 May;89 Suppl 2:S13-20. doi: 10.1016/j.ijgo.2005.01.026.
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Stulberg DL, Crandell B, Fawcett RS. Diagnosis and treatment of basal cell and squamous cell carcinomas. Am Fam Physician. 2004 Oct 15;70(8):1481-8.
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BACKGROUND
Jaros E, Priborsky J. [15 years' clinical experience in cryodestruction of malignant disorders in the anorectum]. Rozhl Chir. 1999 Sep;78(9):473-7. Czech.
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Cestari A, Guazzoni G, dell'Acqua V, Nava L, Cardone G, Balconi G, Naspro R, Montorsi F, Rigatti P. Laparoscopic cryoablation of solid renal masses: intermediate term followup. J Urol. 2004 Oct;172(4 Pt 1):1267-70. doi: 10.1097/01.ju.0000140073.57974.82.
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Powell T, Whelan C, Schwartz BF. Laparoscopic renal cryotherapy: biology, techniques and outcomes. Minerva Urol Nefrol. 2005 Jun;57(2):109-18.
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Goldberg SR, Neifeld JP. Incidentally discovered gallbladder cancer: role of cryotherapy. J Surg Oncol. 2004 Aug 1;87(2):91-4. doi: 10.1002/jso.20075.
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Dong K, Li B, Guan QL, Huang T. Analysis of multiple factors of postsurgical gastroparesis syndrome after pancreaticoduodenectomy and cryotherapy for pancreatic cancer. World J Gastroenterol. 2004 Aug 15;10(16):2434-8. doi: 10.3748/wjg.v10.i16.2434.
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Johnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8. doi: 10.1016/j.gie.2005.05.008.
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Johnston MH. Cryoablation of Dysplasia in Barrett's Esophagus (BE) and Early Stage Esophageal Cancer. Gastrointestinal endoscopy. 2006;63(5):AB223
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Johnston MH. Reversal of barrett's esophagus with cryotherapy. The American journal of gastroenterology. 2003;98:S11
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Shaheen NJ, Greenwald BD, Peery AF, Dumot JA, Nishioka NS, Wolfsen HC, Burdick JS, Abrams JA, Wang KK, Mallat D, Johnston MH, Zfass AM, Smith JO, Barthel JS, Lightdale CJ. Safety and efficacy of endoscopic spray cryotherapy for Barrett's esophagus with high-grade dysplasia. Gastrointest Endosc. 2010 Apr;71(4):680-5. doi: 10.1016/j.gie.2010.01.018.
Reference Type
BACKGROUND
Other Identifiers
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003
Identifier Type: -
Identifier Source: org_study_id
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