trūFreeze® Spray Cryotherapy Patient Registry

Barrett Esophagus Clinical Trial

Official title:

trūFreeze® Spray Cryotherapy Patient Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802203
• Other study ID #: 003
• Status: Completed
• Start date: April 2013
• Est. completion date: April 2022

Study information

• Verified date: July 2022
• Source: US Endoscopy Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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Subjects may be withdrawn prior to this for any of the following reasons: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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: April 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Bronchial Neoplasm
• Bronchial Neoplasms
• Constriction, Pathologic
• Esophageal Dysplasia
• Esophageal Neoplasm
• Esophageal Neoplasms
• Esophageal Stenosis
• Neoplasms
• Stenosis of Bronchus or Trachea

Intervention

Device:
• truFreeze Spray Cryotherapy
spray cryotherapy

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Ahuja Medical Center-CWR University Hosptials	Beachwood	Ohio
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston University Medical Center	Boston	Massachusetts
United States	Massachusetts General Hosptial	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Colorado Denver	Denver	Colorado
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Ochsner Medical Center	Kenner	Louisiana
United States	Scripps Green Hosptial	La Jolla	California
United States	ProHEALTH Care Associates	Lake Success	New York
United States	NYU	New York	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of Rochester/Strong Memorial Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
US Endoscopy Group Inc.

Country where clinical trial is conducted

United States, 

References & Publications (34)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Goldberg SR, Neifeld JP. Incidentally discovered gallbladder cancer: role of cryotherapy. J Surg Oncol. 2004 Aug 1;87(2):91-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Heier SK. Evaluation of candidate therapies for ablation of Barrett's in a canine model. Gastrointestinal endoscopy. 1996;43(4):337

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. — View Citation

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. — View Citation

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. — View Citation

Johnston MH. Cryoablation of Dysplasia in Barrett's Esophagus (BE) and Early Stage Esophageal Cancer. Gastrointestinal endoscopy. 2006;63(5):AB223

Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. Review. — View Citation

Johnston MH. Reversal of barrett's esophagus with cryotherapy. The American journal of gastroenterology. 2003;98:S11

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. — View Citation

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. — View Citation

Kuflik EG. Cryosurgery updated. J Am Acad Dermatol. 1994 Dec;31(6):925-44; quiz 944-6. Review. — View Citation

Laugier P, Berger G. Assessment of echography as a monitoring technique for cryosurgery. Ultrason Imaging. 1993 Jan;15(1):14-24. — View Citation

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. — View Citation

McKelvie P. Cryotherapy in the upper air and food passages. Proc R Soc Med. 1975 Oct;68(10):610. — View Citation

Myers B, Donovan W. Cryosurgery of the anus. South Med J. 1977 Jan;70(1):17-8. — View Citation

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. — View Citation

Powell T, Whelan C, Schwartz BF. Laparoscopic renal cryotherapy: biology, techniques and outcomes. Minerva Urol Nefrol. 2005 Jun;57(2):109-18. Review. — View Citation

Reiser M, Drukier AK, Ultsch B, Feuerbach S. The use of CT in monitoring cryosurgery. Eur J Radiol. 1983 May;3(2):123-8. — View Citation

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. — View Citation

Rodgers BM, Pappelis P. Profound endoesophageal cryotherapy. Cryobiology. 1985 Feb;22(1):86-92. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect efficacy and outcome data related to the use of truFreeze® 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 truFreeze® spray cryotherapy device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.	5 years
Secondary	Collect safety data related to the use of truFreeze® 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 truFreeze® spray cryotherapy device or registry participation should be recorded and reported immediately.	5 years