Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
This study has been terminated.
(Business Reasons)
Sponsor:
CSA Medical, Inc.
Information provided by:
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00747461
First received: September 4, 2008
Last updated: May 27, 2009
Last verified: May 2009
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Benign Airway Disease Sarcoidosis Wegener's Granulomatosis Rhinoscleroma Recurrent Respiratory Papillomatosis(RRP) |
Device: CryoSpray Ablation (tm) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD") |
Resource links provided by NLM:
Further study details as provided by CSA Medical, Inc.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 5 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: CryoSpray Ablation (tm)
- CryoSpray Ablation(TM)System
- Cryotherapy
- Cryosurgery
- Cryospray
- Cryo
The CryoSpray Ablation(TM) System is a cryosurgical device utilizing a low-pressure liquid nitrogen spray tip CSATM Catheter. Medical grade liquid nitrogen is the cryogen used in the device. The device is used to destroy unwanted tissue by the application of extreme cold with the focused application to select tissue. The cryogen is stored in a liquid nitrogen holding tank integrated into the system.
Other Names:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
Publications:
Johnston MH, Horwhat JD, Haluska, Moses FM. Depth of injury following endoscopic spray cryotherapy: EUS assisted evaluation of mucosal ablation and subsequent healing in the swine model (Abstract). Gastrointestinal Endoscopy 51: AB98, 3462, 2000.
Johnston MH. Endoscopic cryotherapy: A new ice age in gastroenterology? Medscape Gastroenterology 2: 187, 2000.
Eastone JA, Horwhat D, Haluska O, Mathews J, Johnston M. Cryoablation of swine esophageal mucosa: A direct comparison to argon plasma coagulation (APC) and multipolar electrocoagulation (MPEC) [Abstract] Gastrointestinal Endoscopy 53: A3448, 2001.
Johnston MH, Eastone JA, Horwhat JD. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98(9 Suppl): A30, S11, 2003.
Johnston MH, Cash BD, Horwhat JD, Johnston LR, Dykes CA, Mays HS. Cryoablation of Barrett's Esophagus (BE) [Abstract]. Gastroenterology 130 (4, Suppl.2): A640, 2006.
Johnston MH, Cash BD, Dykes CA, Mays HS, Johnston LR. Cryoablation of dysplasia in Barrett's Esophagus (BE) and early stage esophageal cancer [Abstract]. Gastrointestinal Endoscopy 63 (5): April, 2006.
| Responsible Party: | Karen McKenzie, Clinical Trials Project Manager, CSA Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00747461 History of Changes |
| Other Study ID Numbers: | 15-00026 |
| Study First Received: | September 4, 2008 |
| Last Updated: | May 27, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by CSA Medical, Inc.:
|
Benign Airway Disease Airway Injury Sarcoidosis |
Wegener's Granulomatosis Rhinoscleroma Recurrent Respiratory Papillomatosis(RRP) |
Additional relevant MeSH terms:
|
Rhinoscleroma Sarcoidosis Wegener Granulomatosis Papilloma Respiratory Tract Infections Papillomavirus Infections Klebsiella Infections Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Skin Diseases, Bacterial Skin Diseases, Infectious Infection Nose Diseases Respiratory Tract Diseases |
Otorhinolaryngologic Diseases Skin Diseases Lymphoproliferative Disorders Lymphatic Diseases Lung Diseases, Interstitial Lung Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Systemic Vasculitis Vasculitis Vascular Diseases Cardiovascular Diseases Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013