TruFreeze™ Airway Obstruction: TAO STUDY

NCT01903850 | Withdrawn Phase 4 DMC

• 1 other identifier: CSA 005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to prospectively assess the efficacy and safety of spray cryotherapy ablation with the truFreeze System in conjunction with mechanical dilation or debridement for the treatment of clinically significant obstructions of the central airways. The primary effectiveness endpoint is the proportion of subjects with a minimum of 25% improvement in luminal patency following SCT treatment and mechanical intervention 30 days (+/- 5 days) following treatment. Additionally, a primary clinical safety endpoint is the reporting of all adverse events.

Conditions

Lung Disease Airways; Lung Diseases, Obstructive; Airway; Obstruction, With Emphysema; Airway Obstruction

Keywords

Benign central airway obstruction; Malignant central airway obstruction; Spray cryotherapy; Endoluminal tumors; Airway granulation tissue

Outcome Measures

Primary Outcomes (1)

• The primary clinical effectiveness endpoint is a minimum of 25% improvement in luminal patency following SCT treatment and mechanical intervention, on the Day 30 assessment following the last SCT treatment.

  The primary efficacy endpoint for statistical analysis and study powering is the proportion of subjects exhibiting an adequate (minimum of 25%) improvement in airway patency on the Day 30 assessment following the last SCT treatment.

  30 - 44 Days (+/- 5 days)

Secondary Outcomes (1)

• Subject symptoms and functional status

  30-44 days (+/- 5 days)

Study Arms (1)

spray cryotherapy

EXPERIMENTAL

spray cryotherapy: 4 -5 second sprays at Baseline (possible additional tx. to be determined at follow up)

Device: spray cryotherapy

Interventions

spray cryotherapy DEVICE

spray cryotherapy

Also known as: truFreeze™ Spray cryotherapy

spray cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with symptomatic, clinically significant central airway obstruction requiring treatment intervention and who are not candidates for surgical resection. The central airway obstruction must be a consequence of any of the following:
• Benign airway strictures
• Primary or secondary endobronchial tumors located in the central airways
• Airway stents complicated by significant granulation tissue
• Subjects (or designated proxies) who are able to provide written informed consent
• Subjects aged 18 years or greater
• Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
• Subjects deemed eligible candidates for spray cryotherapy based on medical history and physical exam

You may not qualify if:

• Subjects undergoing treatment with any other investigational therapy within the month preceding cryotherapy or planned within 1 month following treatment
• a. Subjects with malignant strictures who require chemotherapy/radiation therapy (including investigational therapies) within 30 days will be allowed participation in the study.
• Subjects with extraluminal causes of airway obstruction such as bulky mediastinal adenopathy, or a central mediastinal tumor causing compression of the airway
• Subjects with less than 3 month expected survival
• Subjects who it is anticipated will require stent placement during their initial treatment
• Subjects who are pregnant or nursing, per device instructions for use
• Subjects (or a designated proxy) who are unwilling to provide written informed consent
• Subjects with ECOG performance status greater than 3
• Subjects likely to have difficulty complying with study visit follow-up scheduling
• Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up
• Subjects with uncontrolled coagulopathy or other bleeding disorders

Sponsors & Collaborators

• CSA Medical, Inc.: lead

Related Publications (12)

• Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. doi: 10.1164/rccm.200210-1181SO.

  PMID: 15187010 BACKGROUND

• Johnston CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92. doi: 10.1016/s0016-5107(99)70352-4.

  PMID: 10385730 BACKGROUND

• 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.

  PMID: 19515183 BACKGROUND

• 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.

  PMID: 20363409 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.

  PMID: 20363410 BACKGROUND

• Xue HB, Tan HH, Liu WZ, Chen XY, Feng N, Gao YJ, Song Y, Zhao YJ, Ge ZZ. A pilot study of endoscopic spray cryotherapy by pressurized carbon dioxide gas for Barrett's esophagus. Endoscopy. 2011 May;43(5):379-85. doi: 10.1055/s-0030-1256334. Epub 2011 Mar 24.

  PMID: 21437849 BACKGROUND

• Halsey KD, Chang JW, Waldt A, Greenwald BD. Recurrent disease following endoscopic ablation of Barrett's high-grade dysplasia with spray cryotherapy. Endoscopy. 2011 Oct;43(10):844-8. doi: 10.1055/s-0030-1256649. Epub 2011 Aug 8.

  PMID: 21826629 BACKGROUND

• 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.

  PMID: 21482131 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.

  PMID: 20058314 BACKGROUND

• Krimsky WS, Broussard JN, Sarkar SA, Harley DP. Bronchoscopic spray cryotherapy: assessment of safety and depth of airway injury. J Thorac Cardiovasc Surg. 2010 Mar;139(3):781-2. doi: 10.1016/j.jtcvs.2009.03.051. Epub 2009 Aug 6. No abstract available.

  PMID: 19664781 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.

  PMID: 22516831 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.

  PMID: 22811511 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Obstructive; Bites and Stings; Airway Obstruction

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Respiratory Insufficiency; Respiration Disorders

Study Officials

• Hiran C Fernando, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 19, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 2, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share