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Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD") (ICEtheBAD)

Primary Purpose

Lung Diseases, Obstructive, Sarcoidosis, Wegener's Granulomatosis

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

CryoSpray Ablation

About this trial

This is an interventional treatment trial for Lung Diseases, Obstructive focused on measuring Benign Airway Disease, Airway Injury, Sarcoidosis, Wegener's Granulomatosis, Rhinoscleroma, Recurrent Respiratory Papillomatosis(RRP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryospray Ablation

Arm Description

Experimental CSA (Cryospray Ablation)

Outcomes

Primary Outcome Measures

Improvement in Luminal Patency Following Cryospray Treatment

Secondary Outcome Measures

Treatment Durability

need for additional treatments within specified period

Full Information

NCT ID

NCT00747461

First Posted

September 4, 2008

Last Updated

August 11, 2015

Sponsor

CSA Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00747461

Brief Title

Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")

Acronym

ICEtheBAD

Official Title

Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Terminated

Why Stopped

Business Reasons

Study Start Date

October 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSA Medical, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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)

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Diseases, Obstructive, Sarcoidosis, Wegener's Granulomatosis, Rhinoscleroma, Recurrent Respiratory Papillomatosis

Keywords

Benign Airway Disease, Airway Injury, Sarcoidosis, Wegener's Granulomatosis, Rhinoscleroma, Recurrent Respiratory Papillomatosis(RRP)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cryospray Ablation

Arm Type

Experimental

Arm Description

Experimental CSA (Cryospray Ablation)

Intervention Type

Device

Intervention Name(s)

CryoSpray Ablation

Other Intervention Name(s)

CryoSpray Ablation(TM)System, Cryotherapy, Cryosurgery, Cryospray, Cryo

Intervention Description

Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days

Primary Outcome Measure Information:

Title

Improvement in Luminal Patency Following Cryospray Treatment

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Treatment Durability

Description

need for additional treatments within specified period

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Machuzak, M.D.

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16301023

Citation

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Results Reference

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PubMed Identifier

10385730

Citation

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.

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PubMed Identifier

10734018

Citation

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. doi: 10.1016/s0016-5085(00)70136-3.

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PubMed Identifier

8076761

Citation

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. doi: 10.1016/0016-5085(94)90123-6.

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PubMed Identifier

8995932

Citation

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.

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PubMed Identifier

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Citation

Johnston 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.

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PubMed Identifier

17367523

Citation

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. doi: 10.1186/1477-7819-5-34.

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PubMed Identifier

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Citation

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. doi: 10.1183/09031936.02.00290202.

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Citation

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Citation

Dumot JA. Cryotherapy Ablation for Esophageal HGD or IMCA in High Risk, Non-Surgical Patients. DDW2007 Abstract submission. Cleveland Clinic Foundation (pending publication)

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Citation

Greenwald BD. CryoSpray Ablation of Early Esophageal Cancer. DDW 2007 Abstract submission. University of Maryland Medical Center. (pending publication)

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Citation

Johnston M, Horwhat J, Dubois A, Schoenfeld P. Endoscopic cryotherapy in the swine esophagus: A follow-up study (Abstract). Gastrointestinal Endoscopy 49:AB126, 1999.

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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.

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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.

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Citation

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Citation

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.

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Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")

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