Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.

NCT00754468 | Completed Phase 4 Results DMC

• 1 other identifier: 16-00017
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy (EGD) using surgical resection specimens from subjects undergoing esophagectomy.

Conditions

Barrett's Esophagus; Esophageal Cancer

Keywords

Barrett's Esophagus; Esophageal Cancer; Esophageal Dysplasia; Low Grade Dysplasia; High Grade Dysplasia

Outcome Measures

Primary Outcomes (1)

• Depth of Injury

  histopathological findings analyzed to determine max depth of injury (mm)

  End of Study

Secondary Outcomes (1)

• Side Effects of Subjects Receiving Cryospray Therapy.

  End of Study

Study Arms (2)

Group 1: Cryo Spray Ablation

EXPERIMENTAL

cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds

Device: Cryo Spray Ablation

Group 2: Cryo Spray Ablation

EXPERIMENTAL

cryo spray ablation applied to healthy tissue 2 cycles x20 seconds

Device: Cryo Spray Ablation

Interventions

Cryo Spray Ablation DEVICE

Cryo Spray Ablation 4 cycles x 10 seconds treatment

Group 1: Cryo Spray Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years of age
• Esophagectomy planned based on clinical situation not related to this study.
• Deemed operable based on institutional criteria.

You may not qualify if:

• Pregnant
• Esophageal stricture preventing passage of endoscope or catheter.
• 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 or concurrent endoscopic ablation therapy within 4 cm from the CSA treatment area including, but not limited to, cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation, or argon plasma coagulation.
• Prior radiation therapy which involved the esophagus.

Sponsors & Collaborators

• CSA Medical, Inc.: lead
• University of Miami: collaborator

Study Sites (1)

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Related Publications (18)

• 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: 16301023 BACKGROUND

• 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: 10385730 BACKGROUND

• 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: 10734018 BACKGROUND

• 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: 8076761 BACKGROUND

• 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: 8995932 BACKGROUND

• 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: 14629105 BACKGROUND

• 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: 17367523 BACKGROUND

• 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: 10349923 BACKGROUND

• 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

• Ribeiro A, Bejarano P, Livingstone A, Sparling L, Franceschi D, Ardalan B. Depth of injury caused by liquid nitrogen cryospray: study of human patients undergoing planned esophagectomy. Dig Dis Sci. 2014 Jun;59(6):1296-301. doi: 10.1007/s10620-013-2991-4. Epub 2014 Jan 7.

  PMID: 24395381 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Limitations and Caveats

single center, small number of subjects

Results Point of Contact

• Title: Dr. Alfonso Ribeiro
• Organization: University of Miami

Aribeiro@med.miami.edu

305-243-4000

Study Officials

• Afonso Ribeiro, M.D.

  University of Miami Sylvester Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: February 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 4, 2015
• Results First Posted: November 4, 2015

Record last verified: 2015-10

Locations

US (1)