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trūFreeze® Spray Cryotherapy Patient Registry

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01802203
First Posted: March 1, 2013
Last Update Posted: May 11, 2017
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.
Information provided by (Responsible Party):
CSA Medical, Inc.
  Purpose
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 Intervention
Barrett Esophagus Esophageal Dysplasia Esophageal Neoplasm Esophageal Stenosis Bronchial Neoplasm Stenosis of Bronchus or Trachea Device: truFreeze Spray Cryotherapy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: trūFreeze® Spray Cryotherapy Patient Registry

Resource links provided by NLM:


Further study details as provided by CSA Medical, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 275
Study Start Date: April 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
truFreeze spray cryotherapy
truFreeze Spray Cryotherapy administered as routine clinical care
Device: truFreeze Spray Cryotherapy
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.).

  Eligibility

Information from the National Library of Medicine

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, Senior)
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
Information from the National Library of Medicine

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


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, Pennsylvania
Temple University Health System
Philadelphia, Pennsylvania, United States, 19140
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
CSA Medical, 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

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.
Heier 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. Review.
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.
Graña 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.
Loprinzi CL, Foote RL, Michalak J. Alleviation of cytotoxic therapy-induced normal tissue damage. Semin Oncol. 1995 Apr;22(2 Suppl 3):95-7. Review.
Rodgers BM, Pappelis P. Profound endoesophageal cryotherapy. Cryobiology. 1985 Feb;22(1):86-92.
Laugier P, Berger G. Assessment of echography as a monitoring technique for cryosurgery. Ultrason Imaging. 1993 Jan;15(1):14-24.
Reiser M, Drukier AK, Ultsch B, Feuerbach S. The use of CT in monitoring cryosurgery. Eur J Radiol. 1983 May;3(2):123-8.
Myers B, Donovan W. Cryosurgery of the anus. South Med J. 1977 Jan;70(1):17-8.
McKelvie P. Cryotherapy in the upper air and food passages. Proc R Soc Med. 1975 Oct;68(10):610.
Kuflik EG. Cryosurgery updated. J Am Acad Dermatol. 1994 Dec;31(6):925-44; quiz 944-6. Review.
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.
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.
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.
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.
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.
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. Epub 2012 Jul 18.
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.
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.
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
Holschneider CH. Premalignant and malignant disorders of the uterine cervix. Current Diagnosis and Treatment Obstetrics and Gynecology,. 2007:833-854
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. Review.
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.
Jaros E, Príborský J. [15 years' clinical experience in cryodestruction of malignant disorders in the anorectum]. Rozhl Chir. 1999 Sep;78(9):473-7. Czech.
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.
Powell T, Whelan C, Schwartz BF. Laparoscopic renal cryotherapy: biology, techniques and outcomes. Minerva Urol Nefrol. 2005 Jun;57(2):109-18. Review.
Goldberg SR, Neifeld JP. Incidentally discovered gallbladder cancer: role of cryotherapy. J Surg Oncol. 2004 Aug 1;87(2):91-4.
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.
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.
Johnston MH. Cryoablation of Dysplasia in Barrett's Esophagus (BE) and Early Stage Esophageal Cancer. Gastrointestinal endoscopy. 2006;63(5):AB223
Johnston MH. Reversal of barrett's esophagus with cryotherapy. The American journal of gastroenterology. 2003;98:S11
Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. Review.
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.

Responsible Party: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT01802203     History of Changes
Other Study ID Numbers: CSA-003
First Submitted: February 27, 2013
First Posted: March 1, 2013
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by CSA Medical, 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
Constriction, Pathologic
Barrett Esophagus
Esophageal Neoplasms
Bronchial Neoplasms
Esophageal Stenosis
Pathological Conditions, Anatomical
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bronchial Diseases
Respiratory Tract Diseases


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