| September 4, 2008 |
| May 27, 2009 |
| October 2008 |
| March 2010 (final data collection date for primary outcome measure) |
| The effectiveness endpoint is an improvement in luminal patency following cryospray treatment along with visual confirmation of an absence of scarring and stricturing of the airway. Primary safety endpoint is the reporting of all adverse events. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00747461 on ClinicalTrials.gov Archive Site |
| A measure of treatment durability. If after the initial repeat bronchoscopy, the investigator determines that there is no immediate need for further intervention, then any future bronchoscopy will be performed upon the patient presenting with symptoms. [ Time Frame: 24 months ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD") |
| Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD") |
The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat benign airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB) |
The proposed study is a single center pilot study consisting of up to 10 subjects with benign airway disease. Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first three to seven days after the initial treatment, to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy per week with CSA therapy for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. If disease exists bilaterally, only one side will be sprayed initially. |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
- Benign Airway Disease
- Sarcoidosis
- Wegener's Granulomatosis
- Rhinoscleroma
- Recurrent Respiratory Papillomatosis(RRP)
|
| Device: CryoSpray Ablation (tm) |
| |
- 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 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.
- Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7.
- Champion G, Richter JE, Vaezi MF, Singh S, Alexander R. Duodenogastroesophageal reflux: relationship to pH and importance in Barrett's esophagus. Gastroenterology. 1994 Sep;107(3):747-54.
- Eisen GM, Sandler RS, Murray S, Gottfried M. The relationship between gastroesophageal reflux disease and its complications with Barrett's esophagus. Am J Gastroenterol. 1997 Jan;92(1):27-31.
- Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. Review.
- Cash BD, Johnston LR, Johnston MH. Cryospray ablation (CSA) in the palliative treatment of squamous cell carcinoma of the esophagus. World J Surg Oncol. 2007 Mar 16;5:34.
- Field JK, Youngson JH. The Liverpool Lung Project: a molecular epidemiological study of early lung cancer detection. Eur Respir J. 2002 Aug;20(2):464-79.
- Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. Review.
|
| |
| Terminated |
| 5 |
| March 2011 |
| March 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 18 years of age
- Deemed a candidate for cryotherapy based on physician physical or medical history review
- Deemed operable based on institutional criteria.
Exclusion Criteria:
- Pregnant or nursing
- Planning to sire a child while enrolled in the study
- 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 guidelines.
- Refusal or inability to give consent.
- Concurrent chemotherapy.
- Prior radiation therapy which involved the any area between the vocal chords and the diaphragm
- Medical contraindication or potential problem that would preclude study participation
- Concurrent participation in other experimental studies Uncontrolled coagulopathy or bleeding diathesis
Serious medical illness, including:
- Uncontrolled congestive heart failure
- Uncontrolled angina
- Myocardial infarction
- Cerebrovascular accident within 6 months prior to study entry
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00747461 |
| Karen McKenzie, Clinical Trials Project Manager, CSA Medical, Inc. |
| 15-00026 |
| CSA Medical, Inc. |
|
| Principal Investigator: |
Michael Machuzak, M.D. |
The Cleveland Clinic |
|
|
| CSA Medical, Inc. |
| May 2009 |
