Clinical trial · Interventional
CryoSpray Ablation(tm)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD)
A Multi-Center Study of CryoSpray Ablation(tm)in Malignant Airway Disease to Determine, Safety, and Tissue Effect in the Lung (ICE the MAD)
NCT00748085CI-TRIAL-00018631ICEtheMADterminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Reasons
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety, and tissue effect of the CryoSpray Ablation(TM) System (CryoSpray Ablation(TM), "CSA" or "cryospray therapy") at multiple centers to treat malignant airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CryoSpray Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cryospray Ablation
- description
- Cryospray Ablation 4, 5-second spray cycles
- interventionNames
- Device: CryoSpray Ablation
Primary outcomes (1)
- measure
- Efficacy of the Cryogen on a Tumor Evaluated by Histopathological Data and Visual Inspection Along With Visual Confirmation of Absence of Scarring and Stricturing of the Airway. The Primary Safety Endpoint is the Reporting of All Adverse Events.
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Consists of a Measure of Treatment Efficacy and Improvement in Luminal Patency Assessed by Visual Inspection.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or greater * Deemed a candidate for cryotherapy based on physician physical or medical history review * Deemed inoperable 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 induction chemotherapy. * Radiation therapy within the last 30 days 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
References
Publications (18)
- BACKGROUNDJohnston 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
- BACKGROUNDEll 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. doi: 10.1016/s0016-5085(00)70136-3. PMID 10734018
- BACKGROUNDChampion 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. doi: 10.1016/0016-5085(94)90123-6. PMID 8076761
- BACKGROUNDEisen 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. PMID 8995932
- BACKGROUNDJohnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8. PMID 14629105
- BACKGROUNDCash 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. doi: 10.1186/1477-7819-5-34. PMID 17367523
- BACKGROUNDField 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. doi: 10.1183/09031936.02.00290202. PMID 12212983
- BACKGROUNDPinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.