NCT00748085

Brief Summary

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
5 years until next milestone

Results Posted

Study results publicly available

July 16, 2014

Completed
Last Updated

July 23, 2015

Status Verified

June 1, 2015

Enrollment Period

9 months

First QC Date

September 4, 2008

Results QC Date

June 16, 2014

Last Update Submit

June 30, 2015

Conditions

Lung CancerMesothelioma

Keywords

Malignant Airway DiseaseLung CancerInoperable Lung CancerMesotheliomaEndoluminal Tumor

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Consists of a Measure of Treatment Efficacy and Improvement in Luminal Patency Assessed by Visual Inspection.

    1 year

Study Arms (1)

Cryospray Ablation

EXPERIMENTAL

Cryospray Ablation 4, 5-second spray cycles

Device: CryoSpray Ablation

Interventions

CryoSpray AblationDEVICE

Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment. Subjects may undergo up to one bronchoscopy with CryoSpray Ablation every seven days for a total of four (4) treatments in the first month.

Also known as: CryoSpray Ablation(TM)System, CSA (TM) System, Cryo Spray Therapy, CSA, Cryotherapy, Cryo Spray Ablation
Cryospray Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or greater
  • Deemed a candidate for cryotherapy based on physician physical or medical history review
  • Deemed inoperable based on institutional criteria.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Related Publications (18)

  • 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: 10385730BACKGROUND

  • 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.

    PMID: 10734018BACKGROUND

  • 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.

    PMID: 8076761BACKGROUND

  • 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.

    PMID: 8995932BACKGROUND

  • 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.

    PMID: 14629105BACKGROUND

  • 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.

    PMID: 17367523BACKGROUND

  • 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.

    PMID: 12212983BACKGROUND

  • Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.

    PMID: 10349923BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

  • Johnston MH. Endoscopic cryotherapy: A new ice age in gastroenterology? Medscape Gastroenterology 2: 187, 2000.

    BACKGROUND

  • 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.

    BACKGROUND

  • Johnston MH, Eastone JA, Horwhat JD. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98(9 Suppl): A30, S11, 2003.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.1016/j.gie.2005.05.008.

    PMID: 16301023BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsMesothelioma

Interventions

Drug Delivery SystemsCryotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title
Ann Murphy Legg, Director of Clinical Research
Organization
CSA Medical
alegg@csamedical.com
781-538-4732

Study Officials

  • William S Krimsky, M.D.

    Franklin Square Hospital Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 8, 2008

Study Start

October 1, 2008

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

July 23, 2015

Results First Posted

July 16, 2014

Record last verified: 2015-06

Locations

US(1)